Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Placebo; Drug: Acetaminophen; Drug: Celecoxib

Study type: Interventional

Funder types: Other

Identifiers

NCT04790812

HSC-DB-20-0118

Details and patient eligibility

About

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. .

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

• ASA 3 or higher for physical status classification
• severe pericoronitis associated with third molar to be extracted
• any known allergies to NSAIDs, aspirin, acetaminophen, sulfa drugs
• history of cardiovascular or cerebrovascular disease
• hepatic disease or impairment
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups, including a placebo group

Celecoxib plus Placebo

Placebo Comparator group

Description:

Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure

Treatment:

Drug: Celecoxib

Drug: Placebo

Celecoxib plus Acetaminophen

Active Comparator group

Description:

Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.

Treatment:

Drug: Acetaminophen

Drug: Celecoxib