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Nonsteroidal Anti-inflammatory Drug

Celecoxib for Postoperative Pain

Phase 4
Waitlist Available
Led By Harry D Gilbert, DDS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
American Society of Anesthesiologists (ASA) physical status classification 1 or 2
At least 1 impacted mandibular third molar planned for extraction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any time during the 72 hours after procedure
Awards & highlights

Study Summary

This trial will compare the effects of two different drugs on post-operative pain after impacted third molar surgery.

Who is the study for?
This trial is for healthy individuals with an impacted mandibular third molar (wisdom tooth) that needs extraction. They should not have allergies to NSAIDs, aspirin, acetaminophen, or sulfa drugs; no history of heart or brain blood vessel disease; not pregnant; and without severe dental infection or liver problems.Check my eligibility
What is being tested?
The study tests the effectiveness in managing pain after wisdom tooth surgery using Celecoxib alone versus a combination of Celecoxib and Acetaminophen. Participants will receive these medications preemptively. A placebo group is also included for comparison.See study design
What are the potential side effects?
Celecoxib may cause stomach upset, headache, dizziness, and increased risk of bleeding. Acetaminophen can lead to nausea or liver damage if used excessively. Side effects vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good or mild systemic disease state according to ASA.
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I am planning to have at least one wisdom tooth removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain as Assessed by a Visual Analogue Scale (VAS)
Secondary outcome measures
Number of Participants Who Receive an Emergency Analgesic Intervention
Pain as Assessed by a Categorical Descriptive Questionnaire

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Celecoxib plus AcetaminophenActive Control2 Interventions
Single oral dose of celecoxib 200 mg in combination with acetaminophen 1000 mg 30 to 60 minutes prior to the dental procedure.
Group II: Celecoxib plus PlaceboPlacebo Group2 Interventions
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,916 Total Patients Enrolled
5 Trials studying Postoperative Pain
657 Patients Enrolled for Postoperative Pain
Harry D Gilbert, DDSPrincipal InvestigatorUniversity of Texas School of Dentistry at Houston
Auco DangStudy DirectorUniversity of Texas School of Dentistry at Houston

Media Library

Celecoxib (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT04790812 — Phase 4
Postoperative Pain Research Study Groups: Celecoxib plus Placebo, Celecoxib plus Acetaminophen
Postoperative Pain Clinical Trial 2023: Celecoxib Highlights & Side Effects. Trial Name: NCT04790812 — Phase 4
Celecoxib (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04790812 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the prerequisites to be involved in this clinical experiment?

"This medical trial is searching for around 100 candidates who suffer from postoperative pain and are between 18 to 45 years old."

Answered by AI

Are there any vacancies open to prospective participants in this experiment?

"Affirmative. Clinicaltrials.gov records prove that this research project, initially advertised on April 22nd 2021, is still open for applicants. The investigators are aiming to enrol 100 subjects from 2 separate clinical centres."

Answered by AI

What purpose is the combination of Celecoxib and Acetaminophen commonly used to serve?

"Celecoxib combined with Acetaminophen is regularly prescribed as a remedy for catarrh, but can also be employed to alleviate rhinorrhoea, musculoskeletal pain, and muscle cramping."

Answered by AI

Is the combination of Celecoxib and Acetaminophen considered safe for human use?

"There is a wealth of evidence and approval from the medical community for Celecoxib plus Acetaminophen, thus it was given a rating of 3 out of 3."

Answered by AI

How many study participants are enrolled in this research endeavor?

"Affirmative. The records located on clinicaltrials.gov demonstrate that this medical investigation began recruitment in April 2021 and was recently updated in November 2022. At present, the study is looking to recruit 100 participants from two distinct sites."

Answered by AI

Is this trial open to individuals who have reached the legal age of majority?

"As per the study's inclusionary requirements, participants must be between 18 and 45 years of age."

Answered by AI

Have researchers conducted any investigations into the combined use of Celecoxib and Acetaminophen?

"At present, 126 studies exploring Celecoxib plus Acetaminophen are underway. 31 of these experiments have entered Phase 3 and can be located at 2169 sites across the United States, with the majority being centered in Winston-Salem, North carolina."

Answered by AI
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~16 spots leftby Apr 2025