Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID)
called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food
and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis,
menstrual cramps, and pain.
Healthy normal volunteers between 16 and 35 years of age in general good health who require
third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be
screened with a medical history and oral examination, including dental x-rays as needed to
confirm the need for third molar removal.
Participants will have all four 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 the lower
wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard
anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill
with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine)
in the mouth and a sedative (midazolam) through an arm vein.
After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and
the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is
unrelieved an hour after surgery may request and receive morphine intravenously (through a
vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol
with codeine and the study drug) and instructions for their use. They will also be given a
pain diary to record pain ratings and medications taken at home. A clinic staff member will
telephone patients at home the morning after surgery to ensure they are rating their pain
intensity at the proper time and are taking their medications as instructed.
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)