- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001724
Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction
Evaluation of the Analgesic Effects of Locally Applied Flurbiprofen and Bupivacaine in the Oral Surgery Model
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.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Dental and Craniofacial Research (NIDCR)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Flurbiprofen
Other Study ID Numbers
- 980035
- 98-D-0035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Flurbiprofen
-
Sun Yat-sen UniversityCompleted
-
Beijing Friendship HospitalRecruitingPostoperative Pain | Preemptive Analgesia | Flurbiprofen Axetil | Perioperative Sleep Quality | Postoperative Inflammatory MarkersChina
-
Sun Yat-sen UniversityCompleted
-
Yuzuncu Yıl UniversityCompletedDrug Effect | Drug Use | Oral Soft Tissue ConditionsTurkey
-
Cancer Institute and Hospital, Chinese Academy...Not yet recruitingEsophageal Cancer | Patient-controlled Analgesia | NSAIDs | Perioperative Analgesia | OpioidChina
-
Beijing Friendship HospitalUnknownPostoperative Pain | Preemptive Analgesia | Sex Difference | Flurbiprofen Axetil | Postoperative Sleep Quality
-
Second Affiliated Hospital, School of Medicine,...UnknownPain, Postoperative | AnaplasiaChina
-
Aziende Chimiche Riunite Angelini Francesco S.p.ACross Research S.A.Completed
-
Teikoku Pharma USA, Inc.Completed
-
Jian-jun YangCompletedCatheter Related Bladder DiscomfortChina