Using a Narcotic to Enhance the Numbing Effect of the Local Anesthetic Lidocaine on Inflamed Molar Teeth
CompletedNCT00001952
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 thre…
Study details
- Official title
- Analgesic Effects of Peripherally Administered Opioids in a Clinical Model of Chronic Inflammation
- Conditions
- Healthy
- Inflammation
- Mouth Disease
- Pain
- Sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 1999-11
- Sex
- All
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Men and women whose mandibular molars are either: intact, caries-free, and have no signs or symptoms of pulpal disease or carious, symptomatic (to hot/cold and percussion), but have no evidence of pulpal necrosis or infection. At least one intact caries-free contralateral mandibular molar must be present. Individuals should be healthy and over the age of 16. No history of stomach ulcers, asthma, lung problems, or allergy to lidocaine, fentanyl or any of the standard or test medications. No body weight which is 30% greater or less than standard height-weight tables. No pregnant or lactating females. Also, no females who are sexually active and will not submit to a pregnancy test. No history of taking any analgesics or antihistamines for 24 hr period prior to study. No patients taking steroids or other anti-inflammatory drugs. Willing to accept root canal treatment without parenteral sedation. Willing to participate in data collection procedures. No clinically significant medical history or signs of debilitation including patients with heart, respiratory, renal, or liver dysfunction. No history of personality disorder, alcohol abuse or drug abuse. No chronic use of drugs which would confound assessment including barbituates, anticonvulsants, tranquilizers, antiarrythmics, beta blockers, and antidepressants. No patients whose mandibular molars are heavily restored (i.e., crowns, large fillings). No hypersensitivity to drugs used (epinephrine, lidocaine, fentanyl).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00001952