|
|
|
Tramadol (Ultram, Ultracet) (Ortho-McNeil) is an addictive, abuse-prone opioid medication which the manufacturer admits that it causes "dependence and abuse, including drug-seeking behavior and taking illicit actions to obtain the drug, are not limited to patients with a prior history of opioid dependence" (PDR 2004). However, it is less addictive the standard high potency opiates. It is not currently a controlled substance, but should be. Tramadol's side-effects are those typical of opioids: dizziness, nausea, and constipation. While it is less addictive than full-agonist narcotics, it is much more addictive than doctors have been led to believe. It is certainly highly preferable to other opiates, if an opiate must be used. Suboxone might possibly be a safer opiate for pain, but it has a very high cost and no better at pain relief. Tramadol is much less addictive than Suboxone. Pentazocine/naloxone (Talwin-NX) is another option, if an opiate must be used. When compared to non-addictive pain killers in the only 39 studies I could find, tramadol's record was 3 wins, 31 losses, and 11 ties. Tramadol is inferior. Two wins were against low dose acetaminophen, but tramadol was inferior to high dose acetaminophen in two others. One win was against low dose ketorolac. In one study, tramadol was a little better for pain and a little worse for side-effects. That was rated a tie. In 2002, there with 1714 emergency room overdoses report due to drug addicts taking tramadol to get high, with tramadol involved in 95 drug-related deaths. From 1998 to 2002, tramadol is documented to have been involved in 382 drug-related deaths. According to the DEA, tramadol abuse is most common among street drug addicts, chronic pain patients, and health professionals. http://www.deadiversion.usdoj.gov/drugs_concern/tramadol.htm Tramadol can be used in opiate detoxification. Whether it would have any substitute value as a maintenance treatment of opiate dependence is unknown, but its use as such would not be illegal. I am currently trying it out for this indication, although attention must be given to its abuse potential. Some of my former Suboxone patients are using it at the maximum approved dosage for pain, i.e. 100 mg four times a day and report good satisfaction. Unfortunately, I am not in a position where I can do any type of double-blind research. Abrupt cessation can cause withdrawal symptoms. Abortion Pain Relief Better with Indomethacin: In a DB PC study of 217 women receiving suppositories for post-abortion pain relief, indomethacin (100 mg) led to rescue pain medication (dipyrone) in 5/53, paracetamol (1000 mg) 7/54, tramadol (100 mg) 10/55, and control group with no suppository treatment 22/55 (p<.0001). There was a significant difference in pain levels between the four groups during the 2-h study (p<.05). Indomethacin always had the lowest VAS rank. Efficacy of suppository analgesia in postabortion pain reduction. Lowenstein L, et al. Israel Institute of Technology, Haifa, Israel. Contraception 2006 Oct;74(4):345-8. (loss) Ankle Sprain: Valdecoxib Better than Tramadol with Fewer Side-Effects: In a 7-day DB PC study of 829 patients with acute first- or second-degree ankle sprain, valdecoxib 20 mg either twice daily or once daily (both with 40-mg loading dose) on day 7 significantly reduced pain versus placebo while tramadol did not. On days 4 and 7, more patients resumed normal walking with valdecoxib (45%-47% and 73%-79%) than with placebo (35% and 64%) or tramadol 50 mg 4 times daily (38% and 67%). In contrast to valdecoxib, the number of withdrawals due to adverse events was significantly higher in the tramadol group (12.2% vs 3.4%; P = .0005). The COX-2 Specific Inhibitor Valdecoxib Versus Tramadol in Acute Ankle Sprain: A Multicenter Randomized, Controlled Trial. Ekman EF. Columbia, South Carolina. Am J Sports Med 2006 Feb 13. (loss) Back Pain: Dexketoprofen did Better than Tramadol with Fewer Side-Effects: In a 7-day DB study of 192 Patients with acute low back pain, dexketoprofen 25 mg t.i.d. did better than tramadol 50 mg t.i.d. Paracetamol up to 4 x 500 mg per day was used as rescue medication. The nocturnal pain decreased during the treatments with a difference in therapies of 23% in favor of DKPT. Within the DKPT-group the patients required additional Paracetamol more often only during the 1st day of treatment whereas the patients of the TRAM-group required the additional rescue medication mainly during the first 3 days of treatment. This difference was statistically significant (p = 0.011). Under DKPT treatment patients experienced significantly less adverse events (p = 0.026). Dexketoprofen-trometamol and tramadol in acute lumbago. Metscher B, et al. Berlin-Chemie AG, Berlin. Fortschrit Med Orig 2001 Jan 11;118(4):147-51. (loss) Bile Duct Pain: Dipyrone Much Superior to Tramadol: In a single-blind study of 74 patients with severe or excruciating pain from a stone in the bile duct, metamizole (dipyrone 2.5 mg) was superior to tramadol 100 mg or a pure spasmolytic drug (butylscopolamine 20 mg) when evaluated as the area under the curve (AUC) from baseline to onset of analgesic action (p < 0.05) and the sum of pain intensity differences (SPID) for the observation period of 2 h (p < 0.005). The mean time until the onset of analgesic action occurred was shortest (p < 0.005) for metamizole (10.9 min) compared with tramadol (15.8 min) and butylscopolamine (25.6 min). Metamizole was also more effective for the secondary efficacy endpoint, pain intensity on a 5-point ordinal scale. In the patient's overall assessment of treatment efficacy at the end of the trial, metamizole was rated as by far the most effective drug (p < 0.005). Observer-blind study with metamizole versus tramadol and butylscopolamine in acute biliary colic pain. Schmieder G, et al. DIAS Institute for Drug Investigation, Kirchheim/Munchen, Fed. Rep. of Germany. Arzneimittelforschung 1993 Nov;43(11):1216-21. (loss) C-Section: Tramadol Inferior to Diclofenac: In a DB PC study of 120 c-section patients, tramadol, 100 mg, was inferior to diclofenac 75 mg given IM with the median time to first rescue 197 min with tramadol plus diclofenac, 48 min with tramadol plus placebo, 113 min with diclofenac plus placebo, and 55 min with double placebo (tramadol plus diclofenac versus all other groups, P < 0.05). Postoperative sensitization and pain after cesarean delivery and the effects of single im doses of tramadol and diclofenac alone and in combination. Wilder-Smith CH, et al. University of Cape Town, South Africa. . Anesth Analg 2003 Aug;97(2):526-33. (loss) Cancer Pain: Flupirtine NSAID Superior to Tramadol for Pain with Fewer Side-Effects: In a 4-week DB study of 71 cancer patients with moderate to severe pain, flupirtine 400 mg/day was superior to tramadol 200 mg/day in relieving cancer pain. The final general assessment by the attending doctors of the results achieved was "good" to "very good" in 63% of the patients on flupirtine, and in 46% of those on tramadol. Undesired effects were observed in 6% of the flupirtine patients and in 19% of those taking tramadol. Treatment of tumor pain with flupirtine. Results of a double-blind study versus tramadol. Luben V, et al. Universitat Giessen, Germany. Fortschrit Med 1994 Jul 10;112(19):282-6. (loss) Coronary By-Pass: Etodolac or Diclofenac Better than Tramadol: In a DB study of 60 coronary bypass patients, pain relief was stronger with etodolac (p < 0.05) from postoperative days 2 to 4 and diclofenac (p < 0.05) from postoperative days 3 to 4 compared with tramadol. Amount of additional pain medication and incidence of side effects were significantly less in etodolac compared with tramadol. Pain treatment with a COX-2 inhibitor after coronary artery bypass operation: a randomized trial. Immer FF, et al. University Hospital, Berne, Switzerland. Annals Thor Surg 2003 Feb;75(2):490-5. (loss) Dental Surgery in Children: Ketamine Better than Tramadol: In a DB study of 120 children going through dental surgery with Midazolam (I), Ketamine (II), Zolpidem (III), Midazolam plus Ketamine (IV), Midazolam plus Tramadol (V) and Zolpidem plus Tramadol (VI), Midazolam plus ketamine was found the most effective combination providing a fast and adequate analgo-sedation in anxious and uncooperative child patients. A comparative evaluation of newer sedatives in conscious sedation. Koirala B, et al. College of Dentistry. Dharan, Nepal. . J Clin Pediatr Dentistry 2006 Summer;30(4):273-6. Gynecologic Surgery: Naproxen as Good with Fewer Side-Effects: In a DB study of 91 women following the outpatient VABRA aspiration or hysterosalpingography, the analgetic efficacy (pain, stress and well-being) of Naproxen and Tramadol was identical. Subjective assessment by the patient and the doctor also revealed no differences between Naproxen and Tramadol. Side-effects of Tramadol, however, were significantly more severe than those of Naproxen and this phenomenon was responsible for a lower ability to proceed with normal activities in the Tramadol group. Pain relief during and following outpatient curettage and hysterosalpingography: a double blind study to compare the efficacy and safety of tramadol versus naproxen. Cobra Research Group. Peters AA, et al. Leiden University, The Netherlands. Eur J Obstet Gyn Reprod Biol 1996 May;66(1):51-6. (loss, side-effects). Gynecological Surgery: Lornoxicam as Good as Morphine or Tramadol with Fewer Side-Effects: In a DB study of 89 patients undergoing elective hysterectomy or hysteromyomectomy, PCA lornoxicam did as well as morphine and tramadol for total pain relief: 15.2 vs. 16.4 vs. 15.9 (P > 0.05). Lornoxicam caused considerably fewer adverse events than morphine and tramadol (10%, 27% and 17%). Patient-controlled analgesia with lornoxicam in patients undergoing gynecological surgery. Gong ZY, et al. Beijing 100730, China. . (loss, side-effects) Gynecologic Surgery: Tramadol a Little Better Pain Relief with a Little More Nausea: In a 44 patient DB PC study following elective gynecological surgery, IV tramadol did somewhat better than IV lornoxicam, each with a PCA pump, although both achieved adequate analgesia (p < 0.05). Tramadol had 36% and lornoxicam 27% suffer from nausea (p > 0.05). Comparison of lornoxicam with tramadol in patient-controlled analgesia after gynecological surgery. Karaca M, et al. University of Gaziantep, Turkey. Eur J Gyn Obstet 2006;27(1):78-80. (tie) Hand Surgery: Tramadol Somewhat Better Pain Relief, But More Side-Effects and Least Desirable: In a DB study of 120 patients undergoing ambulatory hand surgery with IV regional anesthesia, oral analgesic tablets of tramadol 100 mg every 6 h, metamizol 1 g every 6 h, and paracetamol (acetaminophen) 1 g every 6 h were compared. Rescue medication consisted of oral dextropropoxyphene 100 mg on demand. The percentage of patients who required supplementary analgesics was 23% with tramadol, 31% with metamizol, and 42% with acetaminophen. Tramadol was the most effective analgesic, as evidenced by low pain scores, least rescue medication, and fewest number of patients with sleep disturbance. However, the incidence of side effects was also increased with tramadol. Seven patients (17.5%) withdrew from the study because of the severity of nausea and dizziness associated with the use of tramadol. Metamizol and acetaminophen provided good analgesia in about 70% and 60% of patients, respectively, with a decreased incidence of side effects. Despite receiving oral analgesic medication, up to 40% of patients undergoing hand surgery experienced inadequate analgesia in this controlled trial. Although tramadol was more effective, its use was associated with the highest frequency and intensity of adverse effects and the most patient dissatisfaction. Metamizol and acetaminophen provided good analgesia with a small incidence of side effects. Postoperative analgesia at home after ambulatory hand surgery: a controlled comparison of tramadol, metamizol, and paracetamol. Rawal N, et al. Orebro, Sweden. . Anesth Analg 2001 Feb;92(2):347-51. (tie) Injection Pain of Rocuronium: Lidocaine and Ondonsetron Both More Effective than Fentanyl or Tramadol: In a 250-patient DB PC study trying to minimize the pain of rocuronium injection, lidocaine 30 mg did better than narcotics tramadol 50 mg, and fentanyl 100 mcg with 74% vs. 60% vs. 30% experiencing no pain vs. 20% for placebo and 56% for ondansetron 4 mg. Researchers concluded that lidocaine was the most effective, and fentanyl the least. The prevention of pain from injection of rocuronium by ondansetron, lidocaine, tramadol, and fentanyl. Memis D, et al. Trakya University, Edirne, Turkey. . Anest Analg 2002 Jun;94(6):1517-20. (loss) Injection Pain of Propofol: Ondansetron as Effective with Fewer Side-Effects than Tramadol: In a DB study of IV tramadol 50 mg. vs. ondansetron 4 mg. in minimizing the pain due to injection of propofol in 100 patients, there was no significant difference of pain between the two, but there was a significant reduction of nausea and vomiting in the ondansetron group (P = 0.033). The prevention of propofol injection pain by tramadol or ondansetron. Memis D, et al. Trakya University, Edirne, Turkey. . (loss, side-effects) Injection Pain of Propofol: Lignocaine as Effective as Tramadol: In a DB PC study of 90 patients recieving propofol injections, there was a significant and equal reduction in the incidence of pain associated with propofol administration in patients pretreated with lignocaine and tramadol (P < 0.05). Role of tramadol in reducing pain on propofol injection. Wong WH, et al. National University Hospital, Singapore. Singapore Med J 2001 May;42(5):193-5. (tie) Hysterectomy: Dipyrone Did Just as Well as Tramadol with Fewer Side-Effects: In a DB study of 151 women undergoing abdominal hysterectomy, IV dipyrone did just as well as IV tramadol for pain relief with very similar use of relief medications. Adverse gastrointestinal effects were more common with tramadol (42.1%) than dipyrone (20.2%) (P <.05). Also, a significantly higher number of tramadol-treated patients required ondansetron to control nausea and vomiting at 1 hour (19% v 7%), 2 hours (26% v 11%), and 24 hours (46% v 29%) (P <.05) after surgery. Efficacy and safety of dipyrone versus tramadol in the management of pain after hysterectomy: a randomized, double-blind, multicenter study. Torres LM, et al. Cadiz, Spain. . (loss, side-effects) Hysterectomy: Tramadol No Better than Metamizol: In a DB study of 101 post-hysterectomy patients using tramadol (100 mg) or metamizol (1.2 g) alone, or combined. After 15 min, they received the same treatment by PCA. All treatments produced equivalent pain relief, per cent efficacy and adverse effects. When drugs were combined in a 1:1 ratio, synergy was present for the analgesic and adverse effects. Use of intravenous patient-controlled analgesia for the documentation of synergy between tramadol and metamizol. Montes A, et al. Hospital Universitario del Mar, Barcelona, Spain. Br J Anesth 2000 Aug;85(2):217-23. (tie) Hysterectomy: Tramadol Slightly Better Pain Relief but More Vomiting: In a 24-hour DB study of 76 women undergoing abdominal hysterectomies, tramadol 100 mg had non-significantly better pain relief than ketorolac 30 mg every 6 hours IV with mean VAS score of 3.6 vs. 4.4 for ketorolac. With tramadol, 38% experienced vomiting vs. 8% for ketorolac. Ketorolac versus tramadol: comparative study of analgesic efficacy in the postoperative pain in abdominal hysterectomy. Olle Fortuny G, et al. Barcelona. . Rev Esp Anesth Reanim 2000 Apr;47(4):162-7. (tie) Hysterectomy: Lornoxicam Better Pain Relief with Fewer Side-Effects: In a 24-hour DB study of 78 women with moderate to severe postoperative hysterectomy pain, Knee Surgery: Lornoxicam is a member of the oxicam group of nonsteroidal antiinflammatory drugs (NSAIDs). It was at least as effective as comparative NSAIDs and more effective than 10 mg morphine when used at doses > or = 8 mg to control pain after oral surgery. In addition, oral doses of lornoxicam of 16-24 mg daily have been more effective than tramadol 300 mg daily in pain following knee surgery. Lornoxicam, a new potent NSAID with an improved tolerability profile. Radhofer-Weite, et al. Pharma Consulting, Linz, Austria. Drugs Today 2000 Jan;36(1):55-76. Details not available. Not counted. Knee Surgery: Lornoxicam Superior to Tramadol: In a DB study of 76 patients with moderate to unbearable pain following arthroscopic reconstruction of the anterior cruciate ligament using the patella bone-tendon-bone technique, a single dose of lornoxicam 16 mg gave significantly greater total pain relief than tramadol 100 mg over the following 8 hours. Lornoxicam had greater analgesic efficacy than tramadol in patients with moderate baseline pain but was of equivalent efficacy in those with severe/unbearable baseline pain. Fewer patients in the lornoxicam group required rescue medication (58% vs. 77%). Patients' global impression of efficacy showed lornoxicam to be superior to tramadol with 82% and 49% of patients, respectively, rating treatment as good, very good, or excellent. Following multiple-dose administration of lornoxicam (8 mg tid) or tramadol (100 mg tid) for 3 days, efficacy profiles similar to those following a single dose were obtained. Thus, slightly fewer patients in the lornoxicam group required rescue medication, and patients' global impression of efficacy again favored lornoxicam. Significantly fewer patients reported one or more adverse events with lornoxicam than with tramadol (14 vs. 24, respectively). Efficacy and tolerability of lornoxicam versus tramadol in postoperative pain. Staunstrup H, et al. Aarhus University Hospital, Denmark. J Clin Pharmacol 1999 Aug;39(8):834-41. Laparoscopic Dye Test: Tramadol Said Better: In a DB study of 60 patients having a laparoscopic dye test using IV tramadol or ketorolac efore induction of general anaesthesia, tramadol had a better analgesic compared to ketorolac for patients undergoing day care gynaecological laparoscopic procedure. Intravenous tramadol vs ketorolac in laparoscopic dye test. Ali A, et al. Riyadh. J College Physicians Surg Pak 2006 Jan;16(1):3-6. Ed: Details were not able to be obtained. Thus, this is not a reliable report, so I did not include it in my results. Litrotripsy: Piroxicam and Tramadol Equal: In a DB study of 171 extracoporeal lithotripsy patients, 40 mg of Piroxicam IM, and 100 mg Tramadol IV did equally well for stone dimensions, duration and number of ESWL shots (p > 0.05) and significant difference was observed for pain with the two drugs used. Pain was more severe as frequency and power increased. Only one intervention was stopped because of pain. Data analysis suggests that tramadol induces more adverse effects. Randomized study comparing piroxicam analgesia and tramadol analgesia during outpatient electromagnetic extracorporeal lithotripsy. Andreou A, et al. Rouen, France. Prog Urol 2006 Apr;16(2):155-9. Lithotripsy: Tenoxicam Better than Fentanyl or Tramadol with Fewer Side-Effects: In a DB study of 120 patients undergoing, neither IV fentanyl 1 microgram/kg, nor IV tramadol HCl 1.5 mg/kg did as well as tenoxicam 0.3 mg/kg when given before lithotripsy. Nausea or vomiting were significantly higher for fentanyl and tramadol vs. tenoxicam (15.0% and 25.0% vs. 0.0%). Oxygen saturation in fentanyl group was also significantly lower than the other two groups (p < 0.01). Prospective and randomized trial of intravenous tenoxicam versus fentanyl and tramadol for analgesia in outpatient extracorporeal lithotripsy. Chia YY, et al. Taiwan, R.O.C. Acta Anesth Sin 1998 Mar;36(1):17-22. (loss) Maxillofacial Surgery: Ketorolac Did as Well for Pain with Fewer Side-Effects: In a DB study of 51 patients ASA I and II undergoing major maxillofacial surgery, ketorolac (30 mg i.v.) at the time of skin closure and repeated after 8 hrs and 16 hrs from the end of the operation did as well as tramadol (100 mg i.v.) or both for pain relief. Only a low number of patients requested opioids administration to achieve adequate analgesia. There were no cases of insufficient analgesia. Vomiting occurred in 41.2% for tramadol vs 11.2% for ketorolac and 35.5% for the combination. Ketorolac vs tramadol in the treatment of postoperative pain during maxillofacial surgery. Zackova M, et al. Bologna, Italy. Minerva Anesth 2001 Sep;67(9):641-6. (loss, side-effects) Migraines: NSAID Diclofenac Just as Good as Tramadol: In a DB study of 40 emergency room patients with severe migraine headaches, intramuscular (IM) tramadol 100 mg did no better than the non-narcotic IM diclofenac sodium 75 mg. Two-hour pain response rate was 80% for both tramadol and diclofenac groups. There were no statistically significant differences among groups in terms of 48-h pain response, rescue treatment, associated symptoms' response, headache recurrence and adverse event rates. Intramuscular tramadol vs. diclofenac sodium for the treatment of acute migraine attacks in emergency department: a prospective, randomised, double-blind study. Engindeniz Z, et al. Uludag University, Turkey, . J Headache Pain 2005 Jun;6(3):143-8. (tie) Peripheral Trauma: Tramadol No Better than IV Acetaminophen or Diclofenac: In a DB study of 131 ER patients with peripheral trauma, IV propacetamol 20 mg/kg, IM piritramide 0.25 mg/kg, IV tramadol 1 mg/kg and IV diclofenac 1 mg/kg were compared. No significant differences were found between groups at any particular time point. In the piritramide group significantly more side effects were noted than in the other groups (p < 0.05). A prospective, open, single blind, randomized study comparing four analgesics in the treatment of peripheral injury in the emergency department. Hoogewijs J, et al. Akademisch Ziekenhuis Vrije Universiteit Brussel, Brussels, Belgium. (tie) Phantom Stump Pain: Amitriptyline Somewhat Better: In a 1-month DB PC study of 94 treatment-naive posttraumatic limb amputees with phantom pain, phantom pain intensity was 1 (0-2) in the 48 tramadol responders (mean dose, 448 mg), 0 (0-0) in the 40 amitriptyline responders (55 mg), and 0 (0-0) in the 2 placebo responders, with similar effects on stump pain. Adverse effects were minor in all groups, but more common with tramadol. Postamputation pain and sensory changes in treatment-naive patients: characteristics and responses to treatment with tramadol, amitriptyline, and placebo. Wilder-Smith CH, et al. Bern, Switzerland. . Anesthesiol 2005 Sep;103(3):619-28. (loss) Post-Surgical Pain: NSAID Dipyrone Just as Good as Tramadol: In a DB study of 151 women with early postoperative pain following abdominal hysterectomy, IV 8 g dipyrone and 500 mg tramadol boluses in the dipyrone group were 3.8 (2.4) and 3.5 (2.5) in the tramadol group, and the percentage of patients seeking rescue medication (dipyrone 27%, tramadol 27%) was identical. Pain scores were very similar. A significantly higher percentage of adverse gastrointestinal effects was found in patients given tramadol (42%) vs. dipyrone (20%) (P <.05). Also, a significantly higher number of tramadol-treated patients required ondansetron to control nausea and vomiting at 1 hour (19% v 7%), 2 hours (26% v 11%), and 24 hours (46% v 29%) (P <.05) after surgery. Efficacy and safety of dipyrone versus tramadol in the management of pain after hysterectomy: a randomized, double-blind, multicenter study. Torres LM, et al. Hospital Universitario Puerta del Mar, Cadiz, Spain. . Reg Anesth Pain Med. 2001 Mar-Apr;26(2):118-24. (loss, side-effects) Post-Abortion Pain: NSAID and Acetaminophen Better than Tramadol: In a DB PC study of 217 women following surgical abortion using suppositories, indomethacin (100 mg) did best followed by acetaminophen (1000 mg), tramadol (100 mg), and control group with no suppository treatment. Pain levels were evaluated by VAS five times - 15, 30, 60, 90 and 120 min after abortion. Dipyrone (1 g po) rescue analgesia was requested by 22/55 women in the control group, 10/55 in the tramadol group, 7/54 in the paracetamol group and 5/53 in the indomethacin group (chi(2)=19.0, p<.0001). Efficacy of suppository analgesia in postabortion pain reduction. Lowenstein L, et al. Israel Institute of Technology, Haifa. Contraception 2006 Oct;74(4):345-8. Post-Appendectomy: Parecoxib Better than Tramadol: In a DB study of 50 patients undergoing open appendectomy with spinal anesthesia, parecoxib 40 mg and tramadol 50 mg IV were administered twice. The mean rescued doses of meperidine were 4.6 and 18.6 mg in parecoxib and tramadol groups (p = 0.005). There was a significantly higher pain score at 24 h (p = 0.01) and sedation score at 6 h (p = 0.003) in the tramadol group. Parecoxib versus tramadol for post-appendectomy pain. Sindhvananda W, et al. Bangkok, Thailand. . (loss) Post-Op Pain: Tramadol as Good as Morphine: In a DB study of 88 patients undergoing major surgical operations (gastrectomy, colectomy and hemicolectomy), PCA i.v.: morphine (at a dilution of 1 mg/ml) did no better than tramadol (at a dilution of 10 mg/ml) after 1 hour, 3 and 18 hours assessment of pain intensity, level of sedation, respiratory and cardiocirculatory parameters. Comparative study of the effects of morphine and tramadol in the treatment of postoperative pain. Casali R, et al. Universita degli Studi, Firenze. Minerva Anesth 2000 Mar;66(3):147-52. Renal Colic: Tramadol Inferior to NSAID Dipyrone: In a DB study of 104 patients suffering from "severe" to "excruciating" colic pain due to a confirmed kidney stone in the ureter, IV 2.5 g dipyrone was more effective for reducing pain than IV 100 mg tramadol, or IV 20 mg butylscopolamine. Only 5 patients receiving dipyrone needed "rescue" medication as compared with 13 patients given tramadol and 11 patients receiving butylscopolamine. Butylscopolamine did non-significantly Better than tramadol. Double-blind study with dipyrone versus tramadol and butylscopolamine in acute renal colic pain. Stankov G, et al. DIAS Institute, Kirchheim/Munchen, Germany. World J Urol 1994;12(3):155-61. (loss) Renal Colic: Tramadol SC Inferior to Ketorolac IM: This is a DB study with good outcome measures. Nicolas Torralba JA, RigabertMontiel M, Banon Perez V, Valdelvira Nadal P, Perez Albacete M. Intramuscular ketorolac compared to subcutaneous tramadol in the initial emergency treatment of renal colic [Ketorolaco intramuscular frente a Tramadol subcutaneo en el tratamiento inicial de urgencia del colico renal]. Archivos Espanoles de Urologia 1999;52(5):435{7. 10427881. (loss) Surgery: Carpal Tunnel Axillary Plexus Block: No Difference Clonidine vs. Sufentanil vs. Tramadol: In a DB PC study of 80 patients undergoing carpal tunnel release performed under axillary plexus block with ropivacaine 0.75% 20 ml comparing tramadol 100 mg, clonidine 1.5 g/kg, sufentanil 20 g vs. placebo, the onset time of anesthesia was sufenanil 11 min; clonidine 12 and tramadol 14 min vs. placebo 20 min. Similar results were obtained for duration of anesthesia and analgesia with the 3 medications each superior to placebo. Only one placebo patient needed surgical infiltration. Adjuvants in the axillary brachial plexus blockade. Comparison between clonidine, sufentanil and tramadol. Antonucci S. Popoli (Pescara), Italy. (tie) Tonsillectomy: Ketoprofen Better than Tramadol: In a DB PC study of 45 children (9-15 years) undergoing tonsillectomy, ketoprofen (2 mg/kg) did better than tramadol (1 mg/kg) after induction of anesthesia. Upon completion of surgery, the study treatment was continued as a 6 h intravenous (i.v.) infusion of another dose of saline, ketoprofen (2 mg/kg) or tramadol (1 mg/kg). Postoperatively, each patient received rescue analgesia with patient-controlled analgesia (PCA) device programmed to deliver 0.5 microg/kg) bolus doses of fentanyl. The total number of requests of PCA-fentanyl was significantly less in ketoprofen group compared with tramadol and placebo groups (P = 0.035 and P = 0.049) and the VAS scores for pain were significantly lower in ketoprofen group compared with tramadol (P = 0.044) or placebo groups (P = 0.018) during the first six postoperative hours. Measured intraoperative blood loss was greater in ketoprofen-treated patients than in those receiving placebo (P = 0.029). Ketoprofen and tramadol for analgesia during early recovery after tonsillectomy in children. Antila H, et al. University of Turku, Finland. Pediatr Anethes 2006 May;16(5):548-53. Tonsillectomy: Tramadol No Better than Diclofenac: In a 14-day single-blind study of 64 patients 11 years and older undergoing bipolar electrocautery tonsillectomy, pain scores were equal for tramadol and diclofenac. There were no significant differences in the incidence of postoperative hemorrhage and hospital readmission for uncontrolled pain. Tramadol vs. diclofenac for posttonsillectomy analgesia. Courtney MJ, et al. Wellington South, New Zealand. . Arch Otolar Head Neck Surg 2001 Apr;127(4):385-8. (tie) Tonsillectomy: Tramadol Better than Low Dose Acetaminophen: In a DB study of 50 children undergoing tonsillectomy, each patient received sufentanil 0.25 microg/kg IV followed with either i.v. propacetamol 30 mg/kg or tramadol 3 mg/kg before surgical incision. For postoperative analgesia, each child received either tramadol drops or acetaminophen suppositories, 6 and 12 h after surgery the first day and three times a day during postoperative days 2 and 3. This dosage of paracetamol was lower than the current recommended dosage. Rescue medication consisted of i.v. diclofenac during the first six postoperative hours and oral ibuprofen afterwards. Pain was significantly lower with tramadol. Double-blind randomized study of tramadol vs. paracetamol in analgesia after day-case tonsillectomy in children. Pendeville PE, et al. Catholic University of Louvain, Brussels, Belgium. Eur J Anesth 2000 Sep;17(9):576-82. (win) Tonsillectomy: Tramadol at Least as Good as Morphine: In a DB randomized study of 66 children undergoing tonsillectomy, tramadol did as well as morphine for sedation and pain relief. There were fewer episodes of postoperative desaturation (<94%) in the tramadol group up to 3 h postoperation, with 26% fewer episodes in the tramadol group during the second hour postoperation (P = 0.02). Tramadol vs morphine during adenotonsillectomy for obstructive sleep apnea in children. Hullett BJ, et al. Princess Margaret Hospital for Children, Perth, WA, Australia. . Pediatr Aneth 2006 Jun;16(6):648-53. Tonsillectomy in Children: Tramadol, Ketamine, and Meperidine All Similar in Effectiveness: In a DB study of 45 children undergoing tonsillectomy comparing intramuscular 0.5 mg/kg ketamine, 1 mg/kg tramadol or 1 mg/kg meperidine on post-operative pain, the effects of ketamine, meperidine and tramadol on post-operative pain following adenotonsillectomy in children were similar. Pain relief for children after adenotonsillectomy. Ertugrul F, et al. AkdenizUniversity, Antalya, Turkey. [email protected]. J Int Med Res 2006 Nov-Dec;34(6):648-54. Thyroidectomy: Tramadol Better than Acetaminophen: In a DB study of 80 thyroidectomy patient of propacetamol, an injectable prodrug of acetaminophen, 2 g vs. IV tramadol, 1.5 mg/kg, there was a slightly better pain reduction with tramadol (p = 0.03), although the usage of rescue medication was no different. More patients complained of nausea and vomiting (p = 0.01) during the first two hours following injection of tramadol, but there was no difference throughout the whole study. Neither drug produced good results. Intravenous tramadol compared to propacetamol for postoperative analgesia following thyroidectomy. Dejonckheere M, et al. Brussels, Belgium. Acta Anesth Belg 2001;52(1):29-33. (win) Tubal Ligation: Tramadol Better than Low Dose Ketorolac: In a DB study of 60 women undergoing tubal ligation, tramadol 1.5 mg/kg did better than ketorolac 10 mg with less postoperative pain in the recovery room (p = 0.007) and at discharge from the day-surgery unit (p = 0.03), and they requested rescue analgesia with morphine less often (p = 0.02) than patients who received ketorolac. Dry mouth was significantly more common after the administration of tramadol (p = 0.009). Three patients in the tramadol group and five in the ketorolac group had overnight admissions due to pain or nausea and vomiting. The analgesic efficacy of tramadol versus ketorolac in day-case laparoscopic sterilisation. Putland AJ, et al. Stockport, UK. Anesth 1999 Apr;54(4):382-5. (win) Dental Pain: Tramadol Inferior to Ibuprofen in Five Studies: In every one of the R.W. Johnson studies, ibuprofen 400 mg was dramatically better than tramadol 75 mg alone for moderate to severe pain after dental surgery and in every study it did better than tramadol combined with acetaminophen 650 mg, although in a couple studies the superiority of ibuprofen did not reach statistical significance. In a couple studies, tramadol plus acetaminophen 650 mg was superior to acetaminophen alone, but in studies using 975 mg of acetaminophen, adding tramadol to the acetaminophen was never of benefit. The side-effects with tramadol was clearly higher than in any other group as was the drop out rate due to inefficacy. Individual Patient Data Meta-Analysis of Single-Dose Oral Tramadol Plus Acetaminophen in Acute Postoperative Pain. Although the studies themselves are unpublished, the author has exposed their dismal results in this published article readily available to dentists anywhere in the world. Edwards JE, et al. University of Oxford. J Pain and Symptom Management 2002;23:121-130. The three ibuprofen studies are detailed in Anesth Prog 2001 Summer;48(3):79-81. (5 losses)
Inferior Study Used by to Promote Opiates: A grossly inferior May 23, 2006, article in the Canadian Medical Association Journal (Furlan et al.) promoting opiates for chronic pain found only 8 randomized articles comparing opiates to non-opiates including the following: In an open, not double-blind study of 35 postherpetic neuralgia patients with a very high 31% drop-out rate, meaning only 21 patients completed the study, tramadol (200-600 mg/d for 6 weeks) did as well as the anti-depressant clomipramine (50-100 mg/d) with or without the phenothiazine l-mepromazine. At 6 weeks, 9 of 10 patients in the tramadol group and of 6 of 11 patients in the clomipramine group rated their analgesia as excellent, good or satisfactory. The incidence of adverse events for all patients was similar in both groups (tramadol 76.5%; clomipramine with or without levomepromazine 83.3%). Treatment of post-herpes zoster pain with tramadol. Results of an open pilot study versus clomipramine with or without levomepromazine. Gobel H, et al. Hopital Universitaire, Kiel, Germany. Drugs 1997;53 Suppl 2:34-9. Ed: This study is so inferior that I had never included it in my collection. It is only listed since it is still being used to promote narcotics.
Tramadol, the Only Non-Narcotic Opiate, vs. Narcotic Opiates Tramadol often does as well as the much more highly addictive opiates in surgery and for pain. It would seem, in view of the small benefits from any opiates, that, if opiates must be used, tramadol would be vastly preferable. The additional of clonidine and magnesium improve pain relief. Child Surgery: Tramadol as Good as Morphine with Fewer Side-Effects: In a DB study of 80 children undergoing urological surgery, morphine 0.1 mg/kg was no better than tramadol 2 mg/kg was no better for pain scores or for use of rescue acetaminophen medication. However, the incidences of allergic rash, itching, sedation and respiratory depression and sedation score were greater in the morphine group than in the tramadol group. A comparison of the postoperative analgesic efficacy of single-dose epidural tramadol versus morphine in children. Demiraran Y, et al. Abant Izzet Baysal University, Turkey. . Br J Anesth 2005 Oct;95(4):510-3. BACKGROUND: Improved clinical outcomes have been documented with combinations of oral analgesic agents, particularly those with complementary activities. However, because not all combinations or dose ratios lead to enhanced analgesia or reduced adverse events (AEs), each combination and dose ratio must be evaluated individually in carefully designed preclinical and clinical trials. OBJECTIVE: The goal of the study was to compare the efficacy and safety of 37.5 mg tramadol/325 mg acetaminophen tablets (T/APAP), 10 mg hydrocodone bitartrate/650 mg acetaminophen tablets (HC/APAP), and placebo in the treatment of postoperative dental pain. METHODS: This was a single-center, double-blind, parallel-group, placebo- and active-controlled study in adults with at least moderate pain (score > or =50 on a 100-mm pain visual analog scale) after extraction of > or =2 impacted third molars. Patients were randomized to receive 1 or 2 T/APAP tablets, 1 HC/APAP tablet, or placebo. Scores for hourly pain relief (PAR), pain intensity difference (PID), and combined PAR and PID (PRID) were based on reported pain at 30 minutes and each successive hour for 8 hours. Primary efficacy measures were summary pain intensity and pain relief scores (total pain relief [TOTPAR], sum of pain intensity differences [SPID], and sum of pain relief and pain intensity differences [SPRIDI) for 0 to 4 hours, 4 to 8 hours, and 0 to 8 hours. Secondary efficacy measures were hourly PAR, PID, and PRID scores; onset and duration of pain relief; time to remedication with a supplemental analgesic agent; and patients' overall assessment of medication. RESULTS: Two hundred adults took part in the study (50 per treatment group) and were included in the efficacy and safety analyses. T/APAP 75/650 mg and HC/APAP were statistically superior to placebo on the primary efficacy measures of TOTPAR, SPID, and SPRID (P < or = 0.024), as well as on hourly PAR, PID, and PRID over 6 hours (P < or = 0.045). All active treatments were statistically superior to placebo in terms of onset of pain relief (P < or = 0.001), duration of pain relief (P < or = 0.024), time to remedication (P < 0.001), and patients' overall assessment of medication (P < 0.001). A statistically significant dose response with T/APAP (2 tablets > 1 tablet > placebo) was seen for TOTPAR, SPID, and SPRID (all, P < or = 0.018). The median time to onset of pain relief was approximately 34.0 minutes with 2 T/APAP tablets and 25.4 minutes with HC/APAP. Although the median time to onset of pain relief was shorter with HC/APAP, two T/APAP tablets had comparable efficacy to HC/APAP. The median time to remedication with a supplemental analgesic agent was 169.0 minutes in the T/APAP 75/650 mg group and 204.0 minutes in the HC/APAP group. However, the duration of pain relief, as defined by time to remedication, was not significantly different between these 2 groups. The overall incidence of AEs was lower with T/APAP (0% treatment-related AEs) than with HC/APAP (4%) or placebo (10%). The incidence of nausea (18% T/APAP, 36% HC/APAP) and vomiting (12% T/APAP, 30% HC/APAP) was approximately 50% lower with 2 T/APAP tablets than with HC/APAP (P < 0.05). CONCLUSIONS: T/APAP tablets provided effective, rapid (< or = 34 minutes), dose-dependent analgesia for the treatment of postoperative dental pain. Two T/APAP tablets provided analgesia comparable to that provided by HC/APAP with better tolerability. A double-blind, single-dose comparison of the analgesic efficacy of tramadol/acetaminophen combination tablets, hydrocodone/acetaminophen combination tablets, and placebo after oral surgery. Fricke JR Jr, et al. Austin Oral Surgery Associates, Texas 78703, USA. Clin Ther 2002 Jun;24(6):953-68. Thoracotomy: Epidural Tramadol Comparable to Morphine: In a DB study of 40 patients who underwent elective muscle-sparing thoracotomy, either 100 mg of tramadol or 4 mg of morphine via the lumbar epidural catheter, each patient was allowed 2 doses in the first 12 hours postoperatively and 2 more in the second 12 hours. the duration of analgesia was significantly shorter with tramadol (p < 0.01). There were no differences between the groups with respect to pain scores at rest or during coughing at any of the time points investigated. Sedation scores were lower with tramadol (p value range, 0.0001-0.05). Morphine showed significantly greater drops in arterial oxygen tension (p value range, 0.0001-0.05). The quality of analgesia achieved with repeated doses of lumbar epidural tramadol after muscle-sparing thoracotomy was comparable to that achieved with repeated doses of lumbar epidural morphine. Comparison of lumbar epidural tramadol and lumbar epidural morphine for pain relief after thoracotomy: a repeated-dose study. Turker G, et al. Uludag University, Turkey. . J Cardiovasc Anest 2005 Aug;19(4):468-74. Clonidine Increases Pain Relief: The addition of droperidol or clonidine to epidural tramadol shortens onset time and increases duration of postoperative analgesia. Gurses et al. Turkey. Can J Anesth 2003 Feb;50(2):147-52. Magnesium Lowers Tramadol Use and Increases Pain Control: A comparative study on the analgesic effect of tramadol, tramadol plus magnesium, and tramadol plus ketamine for postoperative pain management after major abdominal surgery. Turkey. Acta Anesth Scand 2002 Sep;46(8):1025-30. Magnesium IV Reduced Post-Surgical Tramadol Use: In a DB study of 30 Fentanyl Did Better than Tramadol for Colonoscopy Pain: In a poorly designed DB PC study of 150 patients, tramadol did worse than fentanyl. Unfortunately, no non-narcotic alternative was included for comparison. Dig Dis Sci 2006 Sep 29. Fentanyl Worse than Tramadol in Abdominal Surgery Study: In a DB study of 30 patients, patient-controlled IV fentanyl caused more mental confusion and slightly less pain relief than tramadol A comparison of postoperative cognitive function and pain relief with fentanyl or tramadol patient-controlled analgesia. Ng KF, et al. University of Hong Kong, China. . J Clin Anesth 2006 May;18(3):205-10. Tramadol Just As Good As Hydrocodone for Ankle Sprain: In a DB PC study of 603 ankle sprain patients comparing tramadol/acetaminophen versus hydrocodone/acetaminophen versus placebo, tramadol/acetaminophen (one or 2 capsules of 37.5 mg tramadol/325 mg acetaminophen)(n=192) and hydrocodone/acetaminophen (7.5 mg hydrocodone/650 mg acetaminophen)(n=204) provided greater total pain relief than placebo (n=207; P<.001) during the first 4 hours (mean scores 6.6 vs. 6.8 vs. 5.4, respectively; possible range -4 to 16). No efficacy measure was significantly different between the tramadol/acetaminophen and hydrocodone/acetaminophen groups. Tramadol/Acetaminophen or Hydrocodone/Acetaminophen for the Treatment of Ankle Sprain: A Randomized, Placebo-Controlled Trial. Hewitt DJ, et al. Ortho-McNeil, Inc. Ann Emerg Med 2006 Nov 17. Ed: This manufacturer's study was intentionally designed to make tramadol look good by leaving out an NSAID comparator which would almost certainly done as well or more likely better than either tramadol or hydrocodone. Still, tramadol is the better back-up. The use of hydrocodone is unethical and malpractice in my opinion, since neither remedy was that much better than placebo. Morphine No Better than Tramadol in Child Surgery Study: In a DB study of 66 children undergoing tonsillectomy, there was no significant difference between morphine and tramadol in sedation scores 1 h after arrival in recovery (P = 0.24) or at any other time up to 6 h postoperation. There was also no evidence of a difference between the groups in pain scores up to 6 h postoperation. There were fewer episodes of postoperative desaturation (<94%) in the tramadol group up to 3 h postoperation, with 26% fewer episodes in the tramadol group during the second hour postoperation (P = 0.02). Tramadol vs morphine during adenotonsillectomy for obstructive sleep apnea in children. Hullett BJ, et al. Perth, WA, Australia. . Pediatr Anesth 2006 Jun;16(6):648-53. Ed: Since opiates are inferior to non-narcotics for child tonsillectomy pain, they should never be used unless non-narcotics are all contraindicated. In that case, tramadol would be the opiate of choice in view of its much lower abuse potential. Morphine No Better Than Tramadol in Child Open-Heart Surgery: In a DB study of 40 children ages 1-6 undergoing heart surgery for atrial or ventricular septal defect repair and tracheal extubation in the pediatric intensive care unit, morphine did no better than tramadol for pain relief over 48 hours. Postoperatively, children receiving tramadol had earlier awakening from general anesthesia (P = 0.02) and were less sedated at 1 and 2 h postoperatively (P = 0.03 and P = 0.01). Tracheal extubation was earlier in the tramadol group (P = 0.01). Intraoperative administration of tramadol for postoperative nurse-controlled analgesia resulted in earlier awakening and less sedation than morphine in children after cardiac surgery. Chu YC, et al. National Yang-Ming University, Taipei, Taiwan. Anest Analg 2006 Jun;102(6):1668-73. Tramadol Side-Effects Delirium Side-Effect in Elderly: Two elderly patients with intermittent long-term tramadol intake against chronic back pain had 2 years of fluctuating confusional states and cognitive deficits, reversible only after discontinuation of tramadol. Unrecognised long-lasting tramadol-induced delirium in two elderly patients. A case report. Kunig et al. Pharmacopsychiatry 2006 Sep;39(5):194-9. Restless legs syndrome augmentation associated with tramadol. Sleep Medicine 2006 Aug 18. Fractures Increased with Most Opiates: In a case-control study of all subjects with any fracture sustained during the year 2000 (n = 124,655) with each case matched to three controls (n = 373,962) matched on age and gender were randomly drawn from the background population, morphine and other opiates had been used by 10 015 (8.0%) of the case subjects and 12 108 (3.2%) of the controls. After adjustments, morphine was associated with a 47% increase in fracture, fentanyl 123%, methadone 39%, oxycodone 36%, nicomorphine 57% ketobemidone 7%, tramadol 54% and codeine 16%. No increase was present for buprenorphine, pethidine, dextropropoxiphene, and combinations of ASA and codeine. The reason for this may be related to the risk of falls due to central nervous system effects such as dizziness. Fracture risk associated with the use of morphine and opiates. Vestergaard P, et al. Aarhus University Hospital, Denmark. . J Intern Med 2006 Jul;260(1):76-87. Tramadol Similar to NSAIDs in Abuse: In a much less than ideal 12-month open trial study of 11,352 patients, they randomly assigned to either NSAIDs, tramadol or hydrocodone. After the initial randomization, physicians could prescribe whatever medication they desired. Up to nine interviews using a structured questionnaire were conducted over a 12-month period. The primary components of the index were increasing dose without physician approval, use for purposes other than intended, inability to stop its use, and withdrawal. Positive for abuse were 2.5% for NSAIDs, 2.7% for tramadol, and 4.9% for hydrocodone. When more than one hit on the algorithm was used as a measure of persistence, abuse rates were 0.5% for NSAIDs, 0.7% for tramadol, and 1.2% for hydrocodone. A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. Adams EH, et al. Edgar Adams Consulting, Covance, Princeton, New Jersey. . J Pain Symp Managemt 2006 May;31(5):465-76. Ed: Urine drug screens should have been gathered in an inconspicuous manner and screens conducted for patients lying to obtain narcotics to sell them and patients doctor shopping for multiple prescriptions. This was not done. Seizures Usually Occur Within 24 Hours of Abuse; Alcohol Increases Risk: 57 patients with history of tramadol abuse and intoxication were prospectively studied during a 3-year period. Tonic/clonic seizures occurred in 54%: a single seizure in 24%, multiple in 30% after a tramadol dose ranging from 250-2500 mg. Seizures occurred within 24 h after tramadol intoxication in 84%, and later in 16%. Compared to addicts without seizures, the abusers with seizures were younger (p < 0.05). Seizures associated with intoxication and abuse of tramadol. Jovanovic-Cupic V, et al. Institute on Addictions, Belgrade, Serbia and Montenegro. Clin Toxicol (Phila) 2006;44(2):143-6. Seizures More Common with Tricyclics: A reivew of 124 reports of seizures following tramadol therapy received by the FDA through July 31, 1996 found that 23% of the patients were also taking tricyclic antidepressants. Kahn LH, et al. Seizures reported with tramadol. JAMA 278(20):1661; 11/26/97. Seizures are also more common with stroke or head injury patients. Pharmacother 2000 Dec;20(12):1423-31. Serotonin Syndrome with Added to Amitriptyline Case Report: One patient developed serotonin syndrome 3 days after the addition of tramadol to amitriptyline therapy. She deteriorated over four more days and died. Kitson R, et al. Tramadol and severe serotonin syndrome. Anaesthesia 60:934-5; 9/97. Delirium in Two Elderly: Unrecognised long-lasting tramadol-induced delirium in two elderly patients. A case report. Kunig G, et al. Pharmacopsychiatry 2006 Sep;39(5):194-9. Restless legs syndrome augmentation associated with tramadol. Earley CJ, et al. Johns Hopkins. Sleep Medicine 2006 Oct;7(7):592-3. Subcutaneous Nodules: An unusual side-effect of tramadol: subcutaneous nodules. Coskun HS, et al. Suleyman Demirel University Medical Faculty, Isparta, Turkey. J Europ Acad Derm Vener 2006 Sep;20(8):1008-9. Myoclonic seizures induced by tramadol in patients with juvenile myoclonic epilepsy. Moreno-Izco F, et al. Rev Neurol 2006 Aug 16-31;43(4):255. Abuse and Diversion Low: Tramadol was approved by the Food and Drug Administration in 1994 as a non-scheduled drug contingent on the development and implementation of a comprehensive post-marketing surveillance program by an Independent Steering Committee external to Ortho-McNeil Pharmaceutical charged with monitoring abuse and recommending scheduling if unexpectedly high abuse occurred. The program developed by this committee was composed of a variety of studies, and the results of the first three years of the surveillance efforts revealed that the rate of tramadol abuse was low. At a meeting of the FDA in 1998 to reexamine the scheduling status, it was recommended that the scope of the postmarketing surveillance program be broadened to include data on diversion. After a 1-year pilot study, by January 2002, a nationwide diversion survey was fully operational. Survey data suggest that the diversion of tramadol is low, and overall, diversion investigators did not consider tramadol to be a problem. The Diversion of Ultram, Ultracet, and generic tramadol HCL. Inciardi JA, et al. University of Delaware. . J Addict Dis 2006;25(2):53-8. Thomas E. Radecki, M.D., J.D. modern-psychiatry.com |