Celebrex for Pain Relief After Oral Surgery

This study will evaluate the effects of the new anti-inflammatory drug, Celebrex, on relieving pain after oral surgery. It is also designed to assess the drug's selective inhibition of a chemical called cyclooxygenase-2 and not its closely related form, cyclooxygenase-1. This selective inhibition allows pain alleviation without the adverse side effects (e.g., bleeding and stomach upset) often associated with anti-inflammatory drugs.

Healthy volunteers who require removal of their third molars are eligible for this study. Participants will have oral surgery for tooth extraction after receiving a local anesthetic (lidocaine) in the mouth and a sedative (midazolam) through an arm vein. On the evening before and 1 hour before surgery, patients will be given a dose of either the standard anti-inflammatory drug ibuprofen (Advil, Nuprin, Motrin), or Celebrex, or a placebo (a pill with no active ingredient). After surgery, a small piece of tubing will be placed in each extraction site and tied to an adjacent tooth to hold it in place. Samples will be collected from the tubing to measure chemicals involved in pain and inflammation. Patients will stay in the clinic for up to 6 hours after surgery while the anesthetic wears off and will complete pain questionnaires. During that time, they may receive acetaminophen plus codeine (Tylenol 3), if needed, for pain. The tubing then will be removed and the patient discharged with standard pain medication.

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Key information

Conditions

Facial Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

About this study

Prostanoids are mediators that have been implicated in all stages of inflammation. The inhibition of prostanoid synthesis by NSAIDs forms the basis of their therapeutic as well as side effects. NSAIDs directly inhibit cyclooxygenase [COX], which leads to reduction of prostaglandin synthesis and also to gastric erosions, inhibition of platelet aggregation and nephrotoxicity. The identification of the two isoforms of COX lead to the hypothesis that COX-2 is responsible for the production of prostaglandins following tissue injury, while COX-1 is involved in normal homeostasis.

The selective COX-2 inhibitors are believed to be efficacious anti-inflammatory drugs devoid of the side effects associated with the inhibition of COX-1. However, the selectivity of these drugs has only been demonstrated in vitro and ex vivo, which may not be a reliable indicator of the in vivo selectivity. The proposed study aims to evaluate the in vivo selectivity of celecoxib, a drug demonstrated to be a selective inhibitor of COX-2 in vitro in the oral surgery model of acute inflammation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers between the ages of 18-65 years.

Patients will be eligible for this study if the two mandibular molars are classified as partial or full bony impactions.

Exclusion criteria

Patients who are allergic to sulfa-drugs.

Patients who have had asthma, hives or an allergic reaction to aspirin, ibuprofen or any similar drugs.

Patients with gastrointestinal ulcers or a history of gastrointestinal bleeding.

Patients who are pregnant or nursing.

Patients of infection or inflammation [pericoronitis] at either extraction site.

Patients with severe kidney disease.

Patients who are taking any of the following drugs: anti-depressants, diuretics, aspirin on a near daily basis, coumadin or other blood thinners.

Patients who are taking drugs known to inhibit P450 2C9 and drugs metabolized by P450 2D6.

Treatment and study plan

Celebrex

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Nih

Registry information

Official study title

In Vivo Selectivity of Cyclooxygenase Inhibitors in the Oral Surgery Model

Important dates

Study start: 1999
Study completion: 2004
First posted: Sep 28, 2000
Registry last updated: Mar 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed