Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Nov 3, 1999
Current as of December 03, 2023
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...
- 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.
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, United States
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