Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction

2014-08-27 03:56:28 | BioPortfolio


This study will evaluate the ability of a new non-steroidal anti-inflammatory drug (NSAID) called rofecoxib to prevent pain following third molar (wisdom tooth) extraction. The Food and Drug Administration approved rofecoxib in 1999 to treat the symptoms of arthritis, menstrual cramps, and pain.

Healthy normal volunteers between 16 and 35 years of age in general good health who require third molar (wisdom tooth) extraction may be eligible for this study. Candidates will be screened with a medical history and oral examination, including dental x-rays as needed to confirm the need for third molar removal.

Participants will have all four wisdom teeth extracted, and a biopsy (removal of a small piece of tissue) will be taken from the inside of the cheek around the area behind the lower wisdom tooth. On the morning of surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or rofecoxib, or a placebo (a pill with no active ingredient). Before surgery, they will be given a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein.

After the surgery, patients will remain in the clinic for up to 4 hours to monitor pain and the effects of the drug. Patients will complete pain questionnaires. Patients whose pain is unrelieved an hour after surgery may request and receive morphine intravenously (through a vein). After 4 hours, patients will be discharged with additional pain medicines (Tylenol with codeine and the study drug) and instructions for their use. They will also be given a pain diary to record pain ratings and medications taken at home. A clinic staff member will telephone patients at home the morning after surgery to ensure they are rating their pain intensity at the proper time and are taking their medications as instructed.

Patients will return to the clinic 48 hours after surgery with the pain diary and pain relievers. At this visit, another biopsy will be taken under local anesthetic.


Pain and inflammation are predictable sequelae following tissue injury, such as surgery. Conventional treatment for intraoperative and postoperative control of pain includes local anesthetic administered preoperatively and analgesics administered postoperatively. Disadvantages of these approaches include pain during the interval when the effect of local anesthesia dissipates and the postoperatively administered analgesic takes effect and adverse effects of opioid-containing analgesics in ambulatory patients. Research over the past two decades has demonstrated that administering nonsteroidal anti-inflammatory drugs (NSAIDs) preoperatively significantly reduces the intensity and the duration of postoperative pain up to eight hours (Dionne et al., 1978 and Jackson et al., 1989). Parallel clinical investigations suggest that the pre-emptive treatment with a long-acting local anesthetic or an NMDA-antagonist reduces pain at 24 to 72 hours post-surgery (Gordon et al., 1997; Yamamoto et al., 1993; Gordon et al., 1999). This proposed clinical trial will use the oral surgery model to assess the therapeutic efficacy of pre-emptive and preventive treatment with a potent selective COX-2 inhibitor, rofecoxib (Vioxx® (Registered Trademark)), given prior to and following third molar extractions to reduce postoperative pain at 24 and 48 hours post-surgery.

This study is a double-blind, randomized control trial with parallel groups using placebo, ibuprofen, or rofecoxib. Rofecoxib 50 mg will be administered PO 90 minutes before surgery in the Clinical Center at NIH and another 50 mg will be self-administered 24 hours later by the subjects at their homes. This regimen is predicted to suppress the onset and intensity of post-operative dental pain to a greater extent than placebo or a non-selective COX-1/COX-2 inhibitor (ibuprofen). The analgesic effect of the drugs will be estimated by hourly observations over the first four hours after surgery using two different measures of pain intensity, the category scale and a visual analog scale (VAS). It is hypothesized that the pre-emptive administration of a selective COX-2 inhibitor, rofecoxib will inhibit the development of central and peripheral sensitization following tissue injury which manifests as hyperalgesia at later time points.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment






National Institute of Dental And Craniofacial Research (NIDCR)
United States




National Institutes of Health Clinical Center (CC)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:56:28-0400

Clinical Trials [704 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome

Comparing the short-term efficacy of rofecoxib versus placebo. Patients receive rofecoxib or placebo or diclofenac and fill out a patient diary on daytime pain severity during daily activi...

A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement.

A study to compare pre-operative administration of rofecoxib versus post-operative administration of diclofenac or rofecoxib, respectively, in the treatment of post-operative pain after to...

Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer

RATIONALE: Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery. It is not yet known if rofecoxib is effective in t...

A Double-Blind, Double-Dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the ...

A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)

The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients wi...

PubMed Articles [4035 Associated PubMed Articles listed on BioPortfolio]

Can Electronic Health Records Databases Complement Spontaneous Reporting System Databases? A Historical-Reconstruction of the Association of Rofecoxib and Acute Myocardial Infarction.

Several initiatives have assessed if mining electronic health records (EHRs) may accelerate the process of drug safety signal detection. In Europe, Exploring and Understanding Adverse Drug Reactions (...

The impact of attachment insecurity on pain and pain behaviors in experimental pain.

Pain perception and pain behaviors are distinct phenomena with different functions. Pain behaviors are protective in their functions, which include eliciting empathy or caring behaviors from others. M...

Anchoring the numerical pain scale changes pain intensity reports in patients with chronic- but not with acute-pain.

Despite enormous differences between acute and chronic pain, numerical pain scale (NRS) is commonly used in pain research and in clinical practice for assessing the intensity of both acute and chronic...

Chronic pain in breast cancer survivors: nociceptive, neuropathic or central sensitization pain?

The differentiation between acute and chronic pain can be insufficient for an appropriate pain management. The aim of this study was to evaluate the prevalence of the predominant pain type (nociceptiv...

Pain self-efficacy moderates the association between pain and somatization in a community sample.

Background and aims Pain is a common condition. However, only a minority of people experiencing pain develop a chronic pain problem. Factors such as somatization, pain self-efficacy and lack of psycho...

Medical and Biotech [MESH] Definitions

A type of pain that is perceived in an area away from the site where the pain arises, such as facial pain caused by lesion of the VAGUS NERVE, or throat problem generating referred pain in the ear.

Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.

Dull or sharp aching pain caused by stimulated NOCICEPTORS due to tissue injury, inflammation or diseases. It can be divided into somatic or tissue pain and VISCERAL PAIN.

Acute pain that comes on rapidly despite the use of pain medication.

Pain originating from internal organs (VISCERA) associated with autonomic phenomena (PALLOR; SWEATING; NAUSEA; and VOMITING). It often becomes a REFERRED PAIN.

More From BioPortfolio on "Rofecoxib to Prevent Pain After Third Molar (Wisdom Tooth) Extraction"

Quick Search


Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...

Searches Linking to this Trial