Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction
Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)