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Completed

NCT Number: NCT04790812

Preemptive Analgesia With Celecoxib for Acute Dental Pain Management

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. .

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Celebrex, COX-2 selective inhibitor, COX-2 selective NSAID

Acetaminophen

Drug

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

Other names: Tylenol, APAP

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.

Other names: Inactive substance, inert substance

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2021
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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