Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

February 27, 2024 updated by: Harry Gilbert, DDS, The University of Texas Health Science Center, Houston

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

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. .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Celecoxib plus Placebo
Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
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).
Other Names:
  • Celebrex
  • COX-2 selective inhibitor, COX-2 selective NSAID
Drug: Placebo
A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.
Other Names:
  • Inactive substance, inert substance
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.
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).
Other Names:
  • Celebrex
  • COX-2 selective inhibitor, COX-2 selective NSAID
Drug: Acetaminophen
Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.
Other Names:
  • Tylenol, APAP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain as Assessed by a Visual Analogue Scale (VAS)
Time Frame: 3 hours after procedure
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)
Time Frame: 8 hours after procedure
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)
Time Frame: 12 hours after procedure
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)
Time Frame: 18 hours after procedure
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)
Time Frame: 24 hours after procedure
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)
Time Frame: 36 hours after procedure
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)
Time Frame: 48 hours after procedure
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)
Time Frame: 72 hours after procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 3 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 8 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 12 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 18 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 24 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 36 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 48 hours after procedure
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
Pain as Assessed by a Categorical Descriptive Questionnaire
Time Frame: 72 hours after procedure
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
Number of Participants Who Receive an Emergency Analgesic Intervention
Time Frame: Any time during the 72 hours after procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harry D Gilbert, DDS, University of Texas School of Dentistry at Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-DB-20-0118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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