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临床试验/NCT00001952
NCT00001952已完成不适用

Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation

National Institute of Dental and Craniofacial Research (NIDCR)1 个研究点 分布在 1 个国家目标入组 275 人开始时间: 1999年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
275
试验地点
1

研究概览

简要总结

The effectiveness of local anesthetics is reduced if inflammation is present, making it difficult to control pain during such procedures as root canals and wisdom teeth removal. This set of studies will assess the effectiveness of the opioid (synthetic narcotic) fentanyl in enhancing the local anesthetic lidocaine (delivered with epinephrine) when used on inflamed molar teeth.

In the first study, a topical anesthetic patch or a placebo will be placed on the gum tissues next to four or five lower posterior teeth. The patch will removed at either 5, 10, or 15 minutes. An electronic test that sends a light electronic impulse into the tooth, lip sensitivity testing ("Is your lip numb?"), and discomfort reports will be started immediately after removal of the patch and repeated every 5 minutes for 30 minutes. An oral surgeon will then remove the patient's wisdom teeth (tooth).

In the second and third studies, a topical anesthetic will be placed on the gum tissue. An electronic test that sends a light electronic impulse into the tooth, lip sensitivity testing ("Is your lip numb?"), and discomfort reports will be started and done several times throughout the test. Then two small openings, one on each side of the tooth, will be drilled into the bony tissues surrounding the tooth. A narcotic drug fentanyl or a placebo drug will be delivered through these openings, allowing placement of the drug next to the nerves that are difficult to numb. Lidocaine, along with a small amount of epinephrine, will be delivered. An oral surgeon will then remove the patient's wisdom teeth or tooth (study 2) or do a root canal (study 3).

In the fourth study, a topical anesthetic will be placed on the gum tissue. Then two small openings, one on each side of the tooth, will be drilled into the bony tissues surrounding the tooth. A narcotic drug fentanyl or a placebo drug will be delivered through these openings. Lidocaine, along with a small amount of epinephrine, will be delivered at one of three rates (15 patients for each rate). Blood pressure, heart rate, and breathing rate will be taken before the topical anesthetic patch is applied, 2 minutes after, and every 5 minutes for the next 45 minutes. Blood samples will be taken 6 times over the course of 60 minutes. When testing is complete, an oral surgeon will remove the wisdom teeth (tooth). One month later, blood samples will be taken using a different drug delivery method in order to compare results.

详细描述

The clinical efficacy of local anesthetics is reduced in the presence of inflammation, sometimes limiting the ability to perform necessary therapeutic procedures. Recent studies suggest, however, that opiate receptors are expressed in the dental pulp and oral mucosal tissues and increase in number under conditions of inflammation. The proposed clinical study will assess the therapeutic effectiveness of the opioid, fentanyl, to enhance the profoundness of the local anesthetic lidocaine with 1:100,000 epinephrine when used on inflamed mandibular molar teeth. Delivering lidocaine 2% with 1:100,000 epinephrine intraosseously immediately after delivering fentanyl intraosseously is predicted to increase the success rate of local anesthesia on the inflamed pulpal tissues of mandibular molars. Three different strategies will be studied to assess fentanyl as an adjunct to local anesthesia. The first study will assess the efficacy of individual drugs under normal conditions in patients whose mandibular molars have healthy pulpal tissues. Pulpal anesthesia will be measured by an electronic pulp tester and drugs will be delivered intraosseously. A second study will evaluate local anesthetic success using the same drugs and route of administration in patients whose mandibular molars have inflamed pulpal tissues. Root canal treatment will test for the clinical effectiveness of local anesthesia. A third study will assess systemic side effects using different rates of intraosseous drug delivery. This series of studies may provide a rationale for the adjunctive administration of opioids in clinical conditions where inflammation limits the effectiveness of local anesthetics alone.

研究设计

研究类型
Observational

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
National Institute of Dental and Craniofacial Research (NIDCR)
申办方类型
Nih

研究点 (1)

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