Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

Single Dose Oral Celecoxib (With or Without Acetaminophen) for Acute Post-operative Pain Following Impacted Third Molar Surgery.

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. .

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.

A randomized, double-blind, placebo-controlled, prospective clinical trial. Subjects will be given a single oral dose of celecoxib 200 mg with placebo (Group 1), or celecoxib 200 mg in combination with acetaminophen 1000 mg (Group 2) 30 to 60 minutes prior to the dental procedure.

Patient regimen randomization will be achieved by use of a random number generator. The care provider or clinic faculty/nurse will blindly administer the regimen to the patient prior to procedure. A placebo capsule will be used to mimic the acetaminophen capsule to maintain blinding of care provider and patient. Preemptive medications will be dispensed in disposable containers prior to the start of daily operations. The research member tasked with dispensing will not be involved with the administration of medications to patients on the day of surgery. The PI and other members of the research team will not be blinded.

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

Single, preemptive oral dose 200mg of celecoxib. A cyclooxygenase-2 (COX-2) selective inhibitor for pain management. A COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.

A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.

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.

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.

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.

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.

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.

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.

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.

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.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

A questionnaire will ask whether the study participant's pain is dull, aching, throbbing, pulsing, stinging, and/or stabbing. Results will be reported categorically as the number of participants who experience the pain descriptor.

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).

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

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Background information reference to The Centers for Disease Control and Prevention (CDC) on statistics relevant to the opioid epidemic supporting the need for other pain modalities.