Preemptive Analgesia With Celecoxib for Acute Dental Pain Management
Purpose
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. .
Condition
- Pain, Postoperative
Eligibility
- Eligible Ages
- Between 18 Years and 45 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention 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.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
- Masking Description
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Celecoxib plus Placebo |
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure |
|
|
Active Comparator Celecoxib plus Acetaminophen |
Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure. |
|
More Details
- Status
- Completed
- Sponsor
- The University of Texas Health Science Center, Houston
Study Contact
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.