Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction

NCT00050362 | Completed Phase 2

• 2 other identifiers: 03005503-D-0055
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the ability of the drugs rofecoxib and bupivacaine to prevent pain following third molar (wisdom tooth) extraction. Rofecoxib is approved to treat pain of arthritis and menstrual cramps. Bupivacaine is a local anesthetic similar to lidocaine, but longer acting. Healthy normal volunteers between 16 and 35 years of age who are in general good health and require extraction of their two lower wisdom teeth may be eligible for this study. Participants will have their two lower wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind one of the extraction sites. Ninety minutes before surgery, patients will take a dose of either rofecoxib, or a placebo (a pill with no active ingredient) by mouth. Just before surgery, they will receive an injection of either lidocaine or bupivacaine to numb the mouth and a sedative called midazolam (Versed® (Registered Trademark)) through an arm vein to cause drowsiness. After surgery, a small piece of tubing will be placed into one of the two extraction sites. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will remain in the clinic for up to 4 hours after surgery to monitor pain and drug side effects while the anesthetic wears off. During this time, they will complete pain questionnaires every 20 minutes. (Patients whose pain is unrelieved an hour after surgery may request and receive acetaminophen (Tylenol) and codeine.) The tubing then will be removed and they will be discharged with pain medicines (Tylenol, codeine and the study drug) and forms to record pain ratings. They will be given detailed instructions on how and when to take the medicines and how to record information in the pain diary. Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic (lidocaine).

Conditions

Pain; Tooth Extraction

Keywords

Pain; NSAID; Oral Surgery; Hyperalgesia; Preemptive Analgesia

Interventions

Rofecoxib and Bupivacaine 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 third molar extraction willing to undergo 3 visits: 1 screening visit, 1 surgical appointment, and 1 follow-up research-related appointment.
• Between the ages of 16-35 years (based upon eruption patterns and age-related complications associated with surgical extraction of third molars).
• In general good health-American Society of Anesthesiologists (ASA) status I or II (healthy subjects based upon criteria for safe administration of out-patient conscious sedation).
• Willing to undergo observation period for four hours postoperatively.
• Willing to complete a 100 mm visual analog scale and a category scale every 20 minutes for the first 4 postoperative hours, and later at 24 and 48 hours.
• Willing to have a microdialysis probe placed beneath the surgical flap over the first 4 hours post-surgery.
• Willing to have a preoperative biopsy on the day of surgery and a postoperative biopsy at 48 hours.
• Willing to return 48 hours post-operation to turn in completed pain diaries and for the postoperative biopsy.
• Must have two lower partial (rating\&eq;3) or fully impacted (rating\&eq;4) wisdom teeth (mandibular third molars).
• As assessed at the screening visit, the sum of the mandibular third molar surgical difficulty ratings must be between 6 to 8 in order to evaluate subjects experiencing similar pain levels.

You may not qualify if:

• Allergy to aspirin, NSAIDs, or sulfites, amide anesthetics.
• Pregnant or lactating females.
• History of peptic ulcers and/or GI bleeding.
• Chronic use of medications confounding the assessment of the inflammatory response or analgesia, for example, NSAIDS, COX-2 inhibitors, antihistamines, steroids, antidepressants.
• Presence of a clinical sign suggestive of infection, inflammation or pre-existing pain.
• Unusual surgical difficulty (determined from panoramic radiograph or during the actual surgery.

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)

• Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature. 1983 Dec 15-21;306(5944):686-8. doi: 10.1038/306686a0.

  PMID: 6656869 BACKGROUND

• Woolf CJ, Wall PD. Morphine-sensitive and morphine-insensitive actions of C-fibre input on the rat spinal cord. Neurosci Lett. 1986 Feb 28;64(2):221-5. doi: 10.1016/0304-3940(86)90104-7.

  PMID: 3960401 BACKGROUND

• Cook AJ, Woolf CJ, Wall PD, McMahon SB. Dynamic receptive field plasticity in rat spinal cord dorsal horn following C-primary afferent input. Nature. 1987 Jan 8-14;325(7000):151-3. doi: 10.1038/325151a0.

  PMID: 3808072 BACKGROUND

MeSH Terms

Conditions

Pain; Hyperalgesia

Interventions

rofecoxib; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

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

Study Record Dates

• First Submitted: December 4, 2002
• First Posted: December 5, 2002
• Study Start: December 1, 2002
• Study Completion: October 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-10

Locations

US (1)