Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction

Phase 2

Completed

• Conditions: Pain

• Registration Number: NCT00001724
• Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Brief Summary

This study will evaluate the effectiveness of the non-steroidal anti-inflammatory drug flurbiprofen (Ansaid® (Registered Trademark)) in relieving pain following oral surgery. Flurbiprofen is approved by the Food and Drug Administration for treatment of arthritis pain.

Patients 16 years of age and older requiring third molar (wisdom tooth) extraction may be eligible for this study.

Patients will undergo oral surgery to remove two lower third molar teeth. Before surgery, they will be given a local anesthetic (lidocaine with epinephrine) injected in the mouth and a sedative (Versed) infused through a catheter (thin plastic tube) placed in an arm vein. At the time of surgery, patients will also be given flurbiprofen or a placebo formulation (look-alike substance with no active ingredient) directly into the extraction site and a capsule that also may contain flurbiprofen or placebo. One in seven patients will receive only placebo.

All patients will fill out pain questionnaires and stay in the clinic for up to 6 hours for observation of bleeding and medication side effects. Patients who do not have satisfactory pain relief from the test medicine after surgery may request a standard pain reliever. A small blood sample will be collected during surgery and at 15 minutes, one-half hour and 1, 2, 3, 4, 5, 6, 24 and 48 hours after surgery to measure flurbiprofen blood levels. A total of 33 ml (about 2 tablespoons) of blood will be drawn for these tests. Samples collected on the day of surgery will be drawn from the catheter used to administer the sedative; the 24- and 48-hour samples will be taken by needle from an arm or hand vein. Urine samples will also be collected between 4 and 6 hours after surgery and again at 24 and 48 hours after surgery.

Detailed Description

This study proposes to evaluate the analgesic efficacy, tissue response, and adverse effects of microencapsulated preparations of a nonsteroidal anti-inflammatory drug (NSAID) and a long-acting local anesthetic administered into post-extraction sites prior to pain onset. Subjects (N=84) will have two mandibular impacted third molars removed and be randomly allocated to receive one of six possible treatments placed into the sockets: 0 mg (placebo formulation), 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg flurbiprofen, or 50 mg bupivacaine. Each patient in these six groups (N=12/group) will also receive an oral placebo capsule. The seventh group of subjects will receive a placebo at the extraction sites and 25 mg of flurbiprofen orally. Subjects will remain at the clinic for six hours following drug administration to record every 30 minutes the offset of mandibular anesthesia, postoperative pain intensity, side effects, and for observation of recurrent bleeding. Demonstration of a dose-responsive relationship for flurbiprofen at doses lower than needed for analgesia following oral administration will provide the basis for a second study in which an optimal dose of flurbiprofen will be combined with bupivacaine.

Study Timeline

• Study Start: 1997-11
• Study First Submitted: 1999-11-03
• Study First Submitted QC: 1999-11-03
• Study First Posted: 1999-11-04
• Status Verified: 2001-11
• Study Completion: 2001-11
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Institute of Dental And Craniofacial Research (NIDCR); 🇺🇸 Bethesda, Maryland, United States