Capsaicin to Control Pain Following Third Molar Extraction
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抽象
描述
Successful preemptive analgesia strategies are superior to traditional pain management schemes in the management of post-operative pain. However, agents with appropriate pharmacokinetic properties are not readily available. The premise of this double-blind, placebo and positive-controlled clinical study is to evaluate the efficacy of vanilloid agonists as preemptive agents in an oral surgery tissue injury model. Vanilloids are a class of small organic compounds; the most familiar of which is capsaicin, the active ingredient in hot pepper. Binding of capsaicin to the vanilloid-1 receptor produces initial activation and then long-acting desensitization of pain specific neurons. We propose to produce a selective, long-term inactivation of peripheral pain transmission through the local application of capsaicin in the oral mucosa in an effort to prevent or reduce post-operative pain in the oral surgery model. Healthy subjects will be recruited, and following local anesthesia, will be given an intramucosal injection of either capsaicin or placebo. (Or as a positive control, 24 hours later, intravenous Toradol). Subjects will have one lower impacted wisdom tooth extracted under local anesthesia and then will rate their pain. The time of analgesic rescue medication request will be noted. A decrease in post-operative pain and decrease in analgesic use will be taken as a positive effect of the vanilloid for decreasing post-operative pain. We anticipate that through the long term blockade of pain specific fibers pre-operatively that there will be a significant attenuation of post-operative pain development following surgery. This has significant implications for reducing pain and suffering, decreasing analgesic use, and reducing post-operative complications following surgery.
日期
最后验证: | 12/31/2003 |
首次提交: | 01/08/2001 |
提交的预估入学人数: | 01/08/2001 |
首次发布: | 01/09/2001 |
上次提交的更新: | 03/02/2008 |
最近更新发布: | 03/03/2008 |
实际学习开始日期: | 12/31/2000 |
预计完成日期: | 12/31/2003 |
状况或疾病
干预/治疗
Drug: Capsaicin
相
资格标准
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | INCLUSION CRITERIA: Male or female volunteers referred for mandibular third molar extraction with a minimal difficulty rating score of 3-4; the rating will be verified by the oral surgeon at time of surgery. Age between 16-40. ASA status 1 or 2, deemed in good general health (able to tolerate outpatient conscious sedation safely). Willing to return at 24 hours for extraction of 1 tooth and be willing to wait up to 6 hours for post op observation following tooth extraction. Willing to return another 48 hours later for final sensory testing. EXCLUSION CRITERIA: ASA status 3-5 and Emergency operation (E) that do not get a physician clearance; i.e. systemic disturbances that limits the patient's activity. Pregnant or breast-feeding mothers. Allergy to investigational drugs or to red chili peppers. Chronically use of analgesics (not limited to, but including: non-steroidal anti-inflammatory medications, steroids, anti-depressants, anti-convulsants). Presence of chronic disease (e.g. cardiovascular disease, liver disease, kidney disease, diabetes, etc.) |