Evidence and methodology in clinical pain trials with special focus on ketamine
British Journal of Cancer 94, Bell, R. F.; Wisløff, T.; Eccleston, C.; Kalso, C., Controlled clinical trials in cancer pain. How controlled should they be? A qualitative systematic review, 2006, pp. 1559-1567. Copyright Nature Publishing Group, reproduced with permission. http://dx.doi.org/10.1038/sj.bjc.6603162 (134.2Kb)
Journal Pain Symptom Management 26(3), Bell, R. F.; Eccleston, C.; Kalso, E., Ketamine as an adjuvant to opioids for cancer pain. A qualitative systematic review, 2003, pp. 867-875. Copyright Elsevier. http://dx.doi.org/10.1016/S0885-3924(03)00311-7 The Cochrane Database of systematic reviews 1, Bell, R.; Eccleston, C.; Kalso, E., Ketamine as adjuvant to opioids for cancer pain, 2003. Copyright Cochrane Collaboration, reproduced with permission. http://dx.doi.org/10.1002/14651858 (256.9Kb)
Acta Anaesthesiologica Scandinavia 49(10), Bell, R. F.; Dahl, J. B; Moore, R. A.; Kalso, E., Peri-operative ketamine for acute postoperative pain. A quantitative and qualitative systematic review (Cochrane review), 2005, pp. 1405-1428. Copyright Blackwell. Accepted for publication under the understanding that nowhere in the original text do we acknowledge another source for the requested material. Non-exclusive World English Language, one edition, print and electronic version of publication only. http://dx.doi.org/10.1111/j.1399-6576.2005.00814.x The Cochrane Database of Systematic Reviews 1, Bell, R. F.; Dahl, J.B.; Moore, R.A.; Kalso, E., Perioperative ketamine for acute postoperative pain, 2006. Copyright Cochrane Collaboration, reproduced with permission. http://dx.doi.org/10.1002/14651858 (482.5Kb)
Acta Anaesthesiologica Scandinavia 45(5), Bell R. F.; Sivertsen, Å.; Mowinckel, P.; Vindenes, H., A Bilateral clinical model for the study of acute and chronic pain after breast-reduction surgery, 2001, pp. 576-582. Copyright Blackwell. Reprinted under the understanding that nowhere in the original text do we acknowledge another source for the requested material. Non-exclusive World English Language, one edition, print and electronic version of publication only. http://dx.doi.org/10.1034/j.1399-6576.2001.045005576.x (172.8Kb)
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Aims: To establish the evidence base for the use of the NMDA receptor antagonist ketamine in the treatment of acute postoperative pain and cancer pain, and in doing so, to assess the methodology used in acute pain and cancer pain trials. Methods: In paper I a clinical model was developed and tested. Paper II is a quantitative and qualitative Cochrane systematic review on perioperative ketamine for acute postoperative pain. Paper III is a qualitative Cochrane systematic review on ketamine as adjuvant to opioid for cancer pain. Paper IV is a qualitative systematic review of the methodology used in clinical trials of oral opioids for cancer pain. Results: The model developed in Paper I was tested and found to be sensitive. Thirty-seven randomised, controlled trials (RCTs) were included in paper II. The meta-analysis found that perioperative ketamine reduced 24 hr PCA morphine consumption and reduced PONV. In paper III, four RCT’s concerning ketamine as adjuvant to opioid for cancer pain were identified. Two were excluded due to flawed methodology. Both trials found that ketamine improved morphine analgesia. Meta-analysis was not appropriate. Thirty- four RCT’s were included in paper IV. Significant limitations in the trial methodology were identified. Conclusions: There is level 1 (strong) evidence that perioperative ketamine reduces 24 hr PCA morphine consumption, and post-operative nausea and vomiting. Adverse effects were mild or absent.There is currently insufficient evidence to permit conclusions regarding the benefits and harms of ketamine as adjuvant to opioid for cancer pain. Randomised, controlled trials are needed. Clinical pain trials require rigorous methodology if they are to produce reliable results. Recommendations for future analgesic trials in acute and cancer pain are made.