Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction

NCT ID: NCT00001724

Last Updated: 2008-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-11-30
• Study Completion Date: 2001-11-30

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.

Conditions

Pain

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Flurbiprofen

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

Those with a history of aspirin or NSAID-induced asthma will be excluded.

Females of childbearing potential who are not practicing adequate contraception will be excluded.

Pregnant or nursing females will be excluded.

Patients with recent history or present signs of renal, hepatic, endocrine, pulmonary, cardiac, gastrointestinal, neurologic, or cerebral function impairment will be excluded.

Those with psychiatric disorders will be excluded.

Patients who have taken an investigational drug within 30 days of this study will be excluded.

Those who have taken another analgesic, steroid, opioid, or NSAID within 24 hours prior to the study will be excluded.

Those with an absence of bilateral local anesthesia during surgery as evidenced by anesthesia or paresthesia of the lower lip postoperatively will be excluded.

Patients who use drugs which will interact with NSAID such as aspirin, warfarin, probenecid, methotrexate, lithium and diuretics will be excluded.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: lead

Locations

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, United States

Countries

United States

References

Dionne RA. Suppression of dental pain by the preoperative administration of flurbiprofen. Am J Med. 1986 Mar 24;80(3A):41-9. doi: 10.1016/0002-9343(86)90110-5.

Reference Type: BACKGROUND

PMID: 3515923 (View on PubMed)

Moore UJ, Seymour RA, Rawlins MD. The efficacy of locally applied aspirin and acetaminophen in postoperative pain after third molar surgery. Clin Pharmacol Ther. 1992 Sep;52(3):292-6. doi: 10.1038/clpt.1992.144.

Reference Type: BACKGROUND

PMID: 1526087 (View on PubMed)

Allison MC, Howatson AG, Torrance CJ, Lee FD, Russell RI. Gastrointestinal damage associated with the use of nonsteroidal antiinflammatory drugs. N Engl J Med. 1992 Sep 10;327(11):749-54. doi: 10.1056/NEJM199209103271101.

Reference Type: BACKGROUND

PMID: 1501650 (View on PubMed)

Other Identifiers

98-D-0035

Identifier Type: -

Identifier Source: secondary_id

980035

Identifier Type: -

Identifier Source: org_study_id