Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04790812
• Other study ID #: HSC-DB-20-0118
• Status: Completed
• Phase: Phase 4
• Start date: April 22, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

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:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Celecoxib
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).
• Acetaminophen
Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.
• Placebo
A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bauer HC, Duarte FL, Horliana AC, Tortamano IP, Perez FE, Simone JL, Jorge WA. Assessment of preemptive analgesia with ibuprofen coadministered or not with dexamethasone in third molar surgery: a randomized double-blind controlled clinical trial. Oral Maxillofac Surg. 2013 Sep;17(3):165-71. doi: 10.1007/s10006-012-0360-7. Epub 2012 Sep 5. — View Citation

Cicconetti A, Bartoli A, Ripari F, Ripari A. COX-2 selective inhibitors: a literature review of analgesic efficacy and safety in oral-maxillofacial surgery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 Feb;97(2):139-46. doi: 10.1016/j.tripleo.2003.08.032. — View Citation

Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available. — View Citation

Hawkey CJ. COX-1 and COX-2 inhibitors. Best Pract Res Clin Gastroenterol. 2001 Oct;15(5):801-20. doi: 10.1053/bega.2001.0236. — View Citation

Jung YS, Kim MK, Um YJ, Park HS, Lee EW, Kang JW. The effects on postoperative oral surgery pain by varying NSAID administration times: comparison on effect of preemptive analgesia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Nov;100(5):559-63. doi: 10.1016/j.tripleo.2005.02.065. — View Citation

May N, Epstein J, Osborne B. Selective COX-2 inhibitors: a review of their therapeutic potential and safety in dentistry. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Oct;92(4):399-405. doi: 10.1067/moe.2001.115127. — View Citation

Nissen SE, Yeomans ND, Solomon DH, Luscher TF, Libby P, Husni ME, Graham DY, Borer JS, Wisniewski LM, Wolski KE, Wang Q, Menon V, Ruschitzka F, Gaffney M, Beckerman B, Berger MF, Bao W, Lincoff AM; PRECISION Trial Investigators. Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis. N Engl J Med. 2016 Dec 29;375(26):2519-29. doi: 10.1056/NEJMoa1611593. Epub 2016 Nov 13. — View Citation

Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: a meta-analysis. Anesth Analg. 2005 Mar;100(3):757-773. doi: 10.1213/01.ANE.0000144428.98767.0E. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	3 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	8 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	12 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	18 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	24 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	36 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	48 hours after procedure
Secondary	Pain as Assessed by a Categorical Descriptive Questionnaire	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.	72 hours after procedure
Secondary	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

External Links

•   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.