Pain, Postoperative
Conditions
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.
Interventions
DRUGCelecoxib
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).
DRUGAcetaminophen
Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.
DRUGPlacebo
A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by a Visual Analogue Scale (VAS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by a Categorical Descriptive Questionnaire | 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. |
| Number of Participants Who Receive an Emergency Analgesic Intervention | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celecoxib Plus Placebo Single oral dose of celecoxib 200 mg with placebo 30 to 60 minutes prior to the dental procedure
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).
Placebo: A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers. | 23 |
| 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.
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).
Acetaminophen: Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management. | 26 |
| Total | 49 |
Baseline characteristics
| Characteristic | Celecoxib Plus Acetaminophen | Total | Celecoxib Plus Placebo |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 17 | 33.2 years STANDARD_DEVIATION 14.4 | 31.1 years STANDARD_DEVIATION 10.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 26 participants | 49 participants | 23 participants |
| Sex: Female, Male Female | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 22 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 26 |
| other Total, other adverse events | 0 / 23 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 26 |
Outcome results
Primary
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.
Time frame: 36 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 3 score on a scale | Standard Deviation 2 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 4.16 score on a scale | Standard Deviation 3.63 |
Primary
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.
Time frame: 3 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 4 score on a scale | Standard Deviation 3.26 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 2.33 score on a scale | Standard Deviation 3.01 |
Primary
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.
Time frame: 8 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 5.25 score on a scale | Standard Deviation 3.3 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 3.33 score on a scale | Standard Deviation 3.32 |
Primary
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.
Time frame: 12 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 4.25 score on a scale | Standard Deviation 2.62 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 3 score on a scale | Standard Deviation 3.03 |
Primary
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.
Time frame: 18 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 4 score on a scale | Standard Deviation 2.82 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 2.66 score on a scale | Standard Deviation 2.5 |
Primary
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.
Time frame: 24 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 3.25 score on a scale | Standard Deviation 2.5 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 3.33 score on a scale | Standard Deviation 2.42 |
Primary
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.
Time frame: 48 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 1.75 score on a scale | Standard Deviation 1.25 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 4 score on a scale | Standard Deviation 3.63 |
Primary
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.
Time frame: 72 hours after procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Visual Analogue Scale (VAS) | 1.75 score on a scale | Standard Deviation 1.7 |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Visual Analogue Scale (VAS) | 2.83 score on a scale | Standard Deviation 3.48 |
Secondary
Number of Participants Who Receive an Emergency Analgesic Intervention
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).
Time frame: Any time during the 72 hours after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Celecoxib Plus Placebo | Number of Participants Who Receive an Emergency Analgesic Intervention | 0 Participants |
| Celecoxib Plus Acetaminophen | Number of Participants Who Receive an Emergency Analgesic Intervention | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 8 hours after procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 12 hours after procedure
Population: Data were not collected for 1 participant in the Celecoxib plus placebo arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 3 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 18 hours after procedure
Population: Data were not collected from 1 participant in the Celecoxib plus Placebo arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 4 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 24 hours after procedure
Population: Data were not collected from 1 participant in the Celecoxib plus Placebo arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 4 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 36 hours after procedure
Population: Data were not collected from 1 participant in the Celecoxib plus Placebo arm. Data were not collected from 1 participant in the Celecoxib plus Acetaminophen arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 48 hours after procedure
Population: Data were not collected for 1 participant in the Celecoxib plus Placebo arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 3 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 72 hours after procedure
Population: Data were not collected from 1 participant in the Celecoxib plus Placebo arm. Data were not collected from 1 participant in the Celecoxib plus Acetaminophen arm.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 2 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 3 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
Secondary
Pain as Assessed by a Categorical Descriptive Questionnaire
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.
Time frame: 3 hours after procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 1 Participants |
| Celecoxib Plus Placebo | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | Other pain | 1 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | dull pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stinging pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | aching pain | 3 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | No pain | 2 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | throbbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | stabbing pain | 0 Participants |
| Celecoxib Plus Acetaminophen | Pain as Assessed by a Categorical Descriptive Questionnaire | pulsing pain | 0 Participants |