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AVMA policy
 
Use of Placebo Controls in Assessment of New Therapies for Alleviation of Acute Pain in Client-Owned Animals
(Approved by the AVMA Executive Board November 2006)
 

The assessment of the analgesic efficacy and potency of a variety of pharmaceutical agents for use in veterinary clinical practice is an important goal of applied and clinical veterinary research. Well designed and appropriately controlled experimental clinical trials are vital to the development of safe and effective compounds. The practice of using placebo controls in clinical trials was historically justified by the need for statistical clarity and the idea that "rescue" analgesic protocols within a given study would protect study participants, especially those in the control group, from excessive pain. However, the availability of, and clinical experience with, a number of existing effective, and in most cases FDA-approved, pain-relieving compounds currently in use today in veterinary practice significantly diminishes the rationale and justification for including such placebo control groups in prospective studies on acute pain. Presently, clinical researchers expect less than 20% of control (placebo-treated) patients will receive analgesics from currently employed "rescue" protocols. Thus, as an alternative to the use of placebo control groups in studies involving acute pain, the AVMA strongly advocates the use of positive (eg, comparative) control groups. Use of this type of trial protocol, when appropriate, ensures patient protection from unnecessary and unintentional harm, and helps to promote trial compliance. This strategy will still provide useful and relevant information on products that have the potential to induce pain relief in our patients. Further, this strategy is consistent with the AVMA's clear position regarding publications of studies involving pain and suffering in the American Journal of Veterinary Research and Journal of the American Veterinary Medical Association. The instructions to authors state, in part, that manuscripts containing information that suggests that animals were subjected to adverse, stressful, or harsh conditions or treatments will not be considered for publication unless the authors demonstrate convincingly that the knowledge gained was of sufficient value to justify these conditions or treatments.