Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Nov 3, 1999

Keywords

ClinConnect Summary

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 rece...

Gender

ALL

Eligibility criteria

• • Patients of either sex requiring removal of two impacted mandibular third molars (partial bony or soft tissue impaction).
• • 16 years of age of older.
• • Indicates willingness to undergo oral surgery with local anesthesia and intravenous midazolam only.
• • Willing to return for the removal of the remaining maxillary third molars at a second appointment.
• • Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be excluded.
• • 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.