Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Flurbiprofen (Drug)
Phase: Phase 2
Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)
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
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
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
Official title: Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model
Study design: Treatment, Safety/Efficacy Study
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.
Minimum age: N/A.
Maximum age: N/A.
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
Willing to return for the removal of the remaining maxillary third molars at a second
Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be
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
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
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.
Locations and Contacts
National Institute of Dental And Craniofacial Research (NIDCR), Bethesda, Maryland 20892, United States
Dionne RA. Suppression of dental pain by the preoperative administration of flurbiprofen. Am J Med. 1986 Mar 24;80(3A):41-9.
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.
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.
Starting date: November 1997
Ending date: November 2001
Last updated: March 3, 2008