Capsaicin to Control Pain Following Third Molar Extraction

NCT00088686 | Completed Phase 2

• 2 other identifiers: 04024804-D-0248
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Capsaicin to Control Pain Following Third Molar Extraction Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them "hot," belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses. Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits: Visit 1 Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth. Visit 2 Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit. Visit 3 Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed "off-study" no sooner than 1 week following the first visit.

Conditions

Healthy; Tooth Extraction

Keywords

Preemptive Analgesia; Vanilloid; Capsaicin; Acute Pain; Orofacial; Vanilloid Receptor (VR); Visual Analog Scale (VAS); Wisdom Teeth; Third Molar Extraction

Interventions

Capsaicin (Intramucosal Injection) DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female volunteers referred for mandibular third molar extraction with a minimal difficulty rating score of 2 - 3 at the time of screening; rating will be verified by the oral surgeon at time of surgery. (Rating scale: 1 = erupted; 2 = soft tissue impaction; 3 = partial bony impaction; 4 = full bony impaction).
• Age between 16-40.
• ASA status 1 or 2, deemed in good general health (able to tolerate outpatient conscious sedation safely).
• Willing to wait up to 4 hours for post-operative observation.
• Willing to return at 48 hours for a second tissue biopsy.

You may not qualify if:

• 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.
• Chronic 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.).

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Baranowski R, Lynn B, Pini A. The effects of locally applied capsaicin on conduction in cutaneous nerves in four mammalian species. Br J Pharmacol. 1986 Oct;89(2):267-76. doi: 10.1111/j.1476-5381.1986.tb10256.x.

  PMID: 3779210 BACKGROUND

• Berger A, Henderson M, Nadoolman W, Duffy V, Cooper D, Saberski L, Bartoshuk L. Oral capsaicin provides temporary relief for oral mucositis pain secondary to chemotherapy/radiation therapy. J Pain Symptom Manage. 1995 Apr;10(3):243-8. doi: 10.1016/0885-3924(94)00130-D.

  PMID: 7629418 BACKGROUND

• Bevan S, Szolcsanyi J. Sensory neuron-specific actions of capsaicin: mechanisms and applications. Trends Pharmacol Sci. 1990 Aug;11(8):330-3. doi: 10.1016/0165-6147(90)90237-3.

  PMID: 2203194 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 30, 2004
• First Posted: August 2, 2004
• Study Start: July 1, 2004
• Study Completion: October 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-10

Locations

US (1)