Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

NCT04790812 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HSC-DB-20-0118
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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. .

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• Pain as Assessed by a Categorical Descriptive Questionnaire

  3 hours after procedure

• Pain as Assessed by a Categorical Descriptive Questionnaire

  8 hours after procedure

• Pain as Assessed by a Categorical Descriptive Questionnaire

  12 hours after procedure

• Pain as Assessed by a Categorical Descriptive Questionnaire

  18 hours after procedure

• Pain as Assessed by a Categorical Descriptive Questionnaire

  24 hours after procedure

Study Arms (2)

Celecoxib plus Placebo

PLACEBO COMPARATOR

Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure

Drug: Celecoxib; Drug: Placebo

Celecoxib plus Acetaminophen

ACTIVE COMPARATOR

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

Drug: Celecoxib; Drug: Acetaminophen

Interventions

Celecoxib DRUG

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).

Also known as: Celebrex, COX-2 selective inhibitor, COX-2 selective NSAID

Celecoxib plus Acetaminophen; Celecoxib plus Placebo

Acetaminophen DRUG

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

Also known as: Tylenol, APAP

Celecoxib plus Acetaminophen

Placebo DRUG

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

Also known as: Inactive substance, inert substance

Celecoxib plus Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status classification 1 or 2
• at least 1 impacted mandibular third molar planned for extraction

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related 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.

  PMID: 22949122 BACKGROUND

• 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.

  PMID: 14970772 BACKGROUND

• 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.

  PMID: 22336956 BACKGROUND

• 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.

  PMID: 11566042 BACKGROUND

• 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.

  PMID: 16243240 BACKGROUND

• 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.

  PMID: 11598574 BACKGROUND

• 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.

  PMID: 27959716 BACKGROUND

• 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.

  PMID: 15728066 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Limitations and Caveats

Small numbers of subjects analyzed due to not returning pain survey.

Results Point of Contact

• Title: Harry Gilbert, DDS
• Organization: The University of Texas Health Science Center at Houston

Harry.D.Gilbert@uth.tmc.edu

713-486-4315

Study Officials

• Harry D Gilbert, DDS

  University of Texas School of Dentistry at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, Professor - Oral and Maxillofacial Surgery

Model Details: 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.

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: March 10, 2021
• Study Start: April 22, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)