Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Celecoxib plus Placebo<br>Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure | Drug: Celecoxib<br>* 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).<br>* Other names: COX-2 selective inhibitor, COX-2 selective NSAID;Drug: Placebo<br>* A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.<br>* Other names: Inactive substance, inert substance;|
| Active Comparator: Celecoxib plus Acetaminophen<br>Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure. | Drug: Celecoxib<br>* 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).<br>* Other names: COX-2 selective inhibitor, COX-2 selective NSAID;Drug: Acetaminophen<br>* Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.<br>* Other names: Tylenol, APAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 3 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 8 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 12 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 18 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 24 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 36 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 48 hours after procedure | 
| Pain as assessed by a Visual Analogue Scale (VAS) | 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. | 72 hours after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 3 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 8 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 12 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 18 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 24 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 36 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 48 hours after procedure | 
| Pain as assessed by a Categorical Descriptive Questionnaire | 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. | 72 hours after procedure | 
| Number of Participants who Receive an Emergency Analgesic Intervention | 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). | Any time during the 72 hours after procedure |