Overview

Celebrex for Pain Relief After Oral Surgery

Status:
Completed
Trial end date:
2004-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs. Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Treatments:
Celecoxib
Cyclooxygenase Inhibitors
Criteria
INCLUSION CRITERIA:

Healthy volunteers between the ages of 18-65 years.

Patients will be eligible for this study if the two mandibular molars are classified as
partial or full bony impactions.

EXCLUSION CRITERIA:

Patients who are allergic to sulfa-drugs.

Patients who have had asthma, hives or an allergic reaction to aspirin, ibuprofen or any
similar drugs.

Patients with gastrointestinal ulcers or a history of gastrointestinal bleeding.

Patients who are pregnant or nursing.

Patients of infection or inflammation [pericoronitis] at either extraction site.

Patients with severe kidney disease.

Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on
a near daily basis, coumadin or other blood thinners.

Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6.