Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

Phase 4

Completed

Brief Summary: The purpose of this study is to compare the effect on postoperative pain of a single agent nonsteroidal anti-inflammatory drug (NSAID) \[celecoxib plus placebo\] to an NSAID combination \[celecoxib plus acetaminophen\] administered preemptively to patients prior to impacted third molar surgery. .

Detailed Description: This randomized, double-blind, placebo-controlled, prospective clinical trial is designed to compare the postoperative pain reduction of a single agent nonsteroidal anti-inflammatory drug (NSAID) and NSAID combination regimen administered preemptively. Subjects will be given a single oral dose of a cyclooxygenase-2 (COX-2) selective inhibitor (celecoxib 200mg), or celecoxib 200 mg in combination with acetaminophen (APAP 1000 mg) 30 to 60 minutes prior to the procedure. Oral surgery involving at least one impacted mandibular third molar will be performed using a combination of intravenous sedation and local anesthesia following UTHealth School of Dentistry (UTSD) surgical protocol. All subjects will be released with identical postoperative instructions and prescriptions for pain management. Nonopioid pain management will be prescribed as follows: 600mg ibuprofen with 500 mg APAP every 6 hours for the first 3 days, then as needed for pain. Subjects will be asked to document medication consumption, postoperative pain and complications for the following 3 days using a Qualtrics survey. An oral and maxillofacial surgery resident or faculty on call can offer emergency intervention with prescription of an opioid analgesic.

Recruitment & Eligibility

Inclusion Criteria

American Society of Anesthesiologists (ASA) physical status classification 1 or 2
at least 1 impacted mandibular third molar planned for extraction

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Celecoxib plus Placebo	Placebo	Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
Celecoxib plus Placebo	Celecoxib	Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
Celecoxib plus Acetaminophen	Celecoxib	Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.
Celecoxib plus Acetaminophen	Acetaminophen	Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.

Primary Outcome Measures

Name	Time	Method
Pain as Assessed by a Visual Analogue Scale (VAS)	72 hours after procedure	Psychometric response scale to be included in a questionnaire to evaluate pain intensity. A 0-10 pain scale will be used with visual "Faces" to correspond with the numerical values, with 10 indicating worse pain.

Secondary Outcome Measures

Name	Time	Method
Pain as Assessed by a Categorical Descriptive Questionnaire	72 hours after procedure	A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, stabbing, none and/or other. Results will be reported categorically as the number of participants who experience the pain descriptor.
Number of Participants Who Receive an Emergency Analgesic Intervention	Any time during the 72 hours after procedure	Emergency interventions are medications or treatments for postoperative pain not prescribed in study, including medications taken other than those prescribed for after the surgery, calling for prescription of medications other than those prescribed for after the surgery, and seeking outside dental/medical attention (for example: private practice or hospital).