Trial Outcomes & Findings for Preemptive Analgesia With Celecoxib for Acute Dental Pain Management (NCT NCT04790812)
NCT ID: NCT04790812
Last Updated: 2024-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
3 hours after procedure
Results posted on
2024-03-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
33
|
|
Overall Study
Received Intervention
|
23
|
26
|
|
Overall Study
COMPLETED
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
28
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Celecoxib Plus Placebo
n=23 Participants
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.
|
Celecoxib Plus Acetaminophen
n=26 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 10.8 • n=23 Participants
|
35 years
STANDARD_DEVIATION 17 • n=26 Participants
|
33.2 years
STANDARD_DEVIATION 14.4 • n=49 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=23 Participants
|
15 Participants
n=26 Participants
|
27 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=23 Participants
|
11 Participants
n=26 Participants
|
22 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
23 participants
n=23 Participants
|
26 participants
n=26 Participants
|
49 participants
n=49 Participants
|
PRIMARY outcome
Timeframe: 3 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
4 score on a scale
Standard Deviation 3.26
|
2.33 score on a scale
Standard Deviation 3.01
|
PRIMARY outcome
Timeframe: 8 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
5.25 score on a scale
Standard Deviation 3.30
|
3.33 score on a scale
Standard Deviation 3.32
|
PRIMARY outcome
Timeframe: 12 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
4.25 score on a scale
Standard Deviation 2.62
|
3 score on a scale
Standard Deviation 3.03
|
PRIMARY outcome
Timeframe: 18 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
4 score on a scale
Standard Deviation 2.82
|
2.66 score on a scale
Standard Deviation 2.50
|
PRIMARY outcome
Timeframe: 24 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
3.25 score on a scale
Standard Deviation 2.5
|
3.33 score on a scale
Standard Deviation 2.42
|
PRIMARY outcome
Timeframe: 36 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
3 score on a scale
Standard Deviation 2
|
4.16 score on a scale
Standard Deviation 3.63
|
PRIMARY outcome
Timeframe: 48 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
1.75 score on a scale
Standard Deviation 1.25
|
4 score on a scale
Standard Deviation 3.63
|
PRIMARY outcome
Timeframe: 72 hours after procedurePsychometric 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Visual Analogue Scale (VAS)
|
1.75 score on a scale
Standard Deviation 1.70
|
2.83 score on a scale
Standard Deviation 3.48
|
SECONDARY outcome
Timeframe: 3 hours after procedureA 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
1 Participants
|
3 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
1 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
1 Participants
|
2 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 hours after procedureA 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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
2 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
2 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
1 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
0 Participants
|
2 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 hours after procedurePopulation: Data were not collected for 1 participant in the Celecoxib plus placebo arm.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
2 Participants
|
3 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
0 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 hours after procedurePopulation: Data were not collected from 1 participant in the Celecoxib plus Placebo arm.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
1 Participants
|
4 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
1 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 hours after procedurePopulation: Data were not collected from 1 participant in the Celecoxib plus Placebo arm.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
1 Participants
|
4 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
1 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 36 hours after procedurePopulation: 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.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=5 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
1 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
2 Participants
|
2 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
0 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 hours after procedurePopulation: Data were not collected for 1 participant in the Celecoxib plus Placebo arm.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
2 Participants
|
3 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 72 hours after procedurePopulation: 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.
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.
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=3 Participants
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.
|
Celecoxib Plus Acetaminophen
n=5 Participants
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.
|
|---|---|---|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stinging pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
stabbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
dull pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
aching pain
|
2 Participants
|
1 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
throbbing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
pulsing pain
|
0 Participants
|
0 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
No pain
|
1 Participants
|
3 Participants
|
|
Pain as Assessed by a Categorical Descriptive Questionnaire
Other pain
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Any time during the 72 hours after procedureEmergency 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).
Outcome measures
| Measure |
Celecoxib Plus Placebo
n=4 Participants
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.
|
Celecoxib Plus Acetaminophen
n=6 Participants
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.
|
|---|---|---|
|
Number of Participants Who Receive an Emergency Analgesic Intervention
|
0 Participants
|
0 Participants
|
Adverse Events
Celecoxib Plus Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Celecoxib Plus Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Harry Gilbert, DDS
The University of Texas Health Science Center at Houston
Phone: 713-486-4315
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place