Clinical trial NCT04790812: Preemptive Analgesia With Celecoxib for Acute Dental Pain Management
Official title: Single Dose Oral Celecoxib (With or Without Acetaminophen) for Acute Post-operative Pain Following Impacted Third Molar Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief 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. .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 3 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 8 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 12 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 18 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 24 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 36 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 48 hours after procedure
measure: Pain as Assessed by a Visual Analogue Scale (VAS)
timeFrame: 72 hours after procedure
Secondary outcomes:
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 3 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 8 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 12 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 18 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 24 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 36 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 48 hours after procedure
measure: Pain as Assessed by a Categorical Descriptive Questionnaire
timeFrame: 72 hours after procedure
measure: Number of Participants Who Receive an Emergency Analgesic Intervention
timeFrame: Any time during the 72 hours after procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: University of Texas School of Dentistry at Houston
name: Harry D Gilbert, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.