Trial Outcomes & Findings for Celecoxib as a Post-tonsillectomy Pain Medication (NCT NCT00583453)
NCT ID: NCT00583453
Last Updated: 2017-03-29
Results Overview
Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
day of procedure through post-operative day 10
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
Celecoxib as Experimerimental Intervention
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo Control, Active Comparator
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
|
Overall Study
COMPLETED
|
9
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Celecoxib as Experimerimental Intervention
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo Control, Active Comparator
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Overall Study
discontinued intervention
|
0
|
2
|
Baseline Characteristics
Celecoxib as a Post-tonsillectomy Pain Medication
Baseline characteristics by cohort
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=8 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
25.1 years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
25.0 years
STANDARD_DEVIATION 3.3 • n=107 Participants
|
25.0 years
STANDARD_DEVIATION 3.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
8 participants
n=107 Participants
|
17 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: day of procedure through post-operative day 10Pain score as reported by participant, measured on a 10 point scale, where 0 = none and 10 = unbearable, collected once daily.
Outcome measures
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=6 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Self-reported Pain Score
Maximum pain, day 1
|
5.0 pain score (units on a scale)
Standard Error 0.6
|
6.0 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
maximum pain, averaged across days 2 to 4
|
5.1 pain score (units on a scale)
Standard Error 0.6
|
6.0 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
maximum pain, averaged across days 5 to 7
|
4.4 pain score (units on a scale)
Standard Error 0.6
|
5.9 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
maximum pain, averaged across days 8 to 10
|
3.6 pain score (units on a scale)
Standard Error 0.6
|
4.0 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
Average pain, day 1
|
6.1 pain score (units on a scale)
Standard Error 1.0
|
7.3 pain score (units on a scale)
Standard Error 0.8
|
|
Self-reported Pain Score
Average pain, averaged across days 2 to 4
|
6.2 pain score (units on a scale)
Standard Error 0.9
|
7.6 pain score (units on a scale)
Standard Error 0.8
|
|
Self-reported Pain Score
Average pain, averaged across days 5 to 7
|
6.1 pain score (units on a scale)
Standard Error 0.9
|
7.4 pain score (units on a scale)
Standard Error 0.8
|
|
Self-reported Pain Score
Average pain, averaged across days 8 to 10
|
4.9 pain score (units on a scale)
Standard Error 0.9
|
5.7 pain score (units on a scale)
Standard Error 0.8
|
|
Self-reported Pain Score
Pain with drinking, day 1
|
5.7 pain score (units on a scale)
Standard Error 0.9
|
6.7 pain score (units on a scale)
Standard Error 0.8
|
|
Self-reported Pain Score
Pain with drinking, averaged across days 2 to 4
|
5.4 pain score (units on a scale)
Standard Error 0.8
|
6.6 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
Pain with drinking, averaged across days 5 to 7
|
4.9 pain score (units on a scale)
Standard Error 0.8
|
5.9 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
Pain with drinking, averaged across days 8 to 10
|
3.9 pain score (units on a scale)
Standard Error 0.8
|
4.1 pain score (units on a scale)
Standard Error 0.7
|
|
Self-reported Pain Score
Activity, day 1
|
2.8 pain score (units on a scale)
Standard Error 0.9
|
4.5 pain score (units on a scale)
Standard Error 1.0
|
SECONDARY outcome
Timeframe: From operative day through 10 days post-operativeActivity level, reported by participant utilizing a 10-point ordinal scale (0 = no activity, 10 = return to normal activities). Activity level was measured was collected once daily.
Outcome measures
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=6 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Self-reported Activity Level
Average, days 8 to 10
|
7.4 Activity score (units on a scale)
Standard Error 0.7
|
5.7 Activity score (units on a scale)
Standard Error 0.9
|
|
Self-reported Activity Level
Day 1
|
2.8 Activity score (units on a scale)
Standard Error 0.9
|
4.5 Activity score (units on a scale)
Standard Error 1.0
|
|
Self-reported Activity Level
Average, days 2 to 4
|
3.1 Activity score (units on a scale)
Standard Error 0.7
|
4.1 Activity score (units on a scale)
Standard Error 0.9
|
|
Self-reported Activity Level
Average, days 5 to 7
|
5.4 Activity score (units on a scale)
Standard Error 0.7
|
3.7 Activity score (units on a scale)
Standard Error 0.9
|
SECONDARY outcome
Timeframe: From operative day through 10 days post-operativeParticipant reported acetaminophen use and its equivalent. Medication use was collected from reported participant journals.
Outcome measures
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=6 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Acetaminophen Equivalent Use
Day 1
|
2074 mg
Standard Error 407
|
3006 mg
Standard Error 498
|
|
Acetaminophen Equivalent Use
Average, days 2 to 4
|
2245 mg
Standard Error 356
|
2934 mg
Standard Error 436
|
|
Acetaminophen Equivalent Use
Average, days 5 to 7
|
2028 mg
Standard Error 356
|
3610 mg
Standard Error 436
|
|
Acetaminophen Equivalent Use
Average, days 8 to 10
|
1418 mg
Standard Error 356
|
2483 mg
Standard Error 436
|
SECONDARY outcome
Timeframe: From operative day through 10 days post-operativeThe incidence of post-operative hemorrhage, defined as post-operative bleeding requiring medical intervention or hospitalization during the 10 day post-operative follow-up period.
Outcome measures
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=6 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Incidence of Post-operative Hemorrhage
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From operative day through 10 days post-operativeParticipant reported mophine equivalent use
Outcome measures
| Measure |
Celecoxib 200 mg Tablets
n=9 Participants
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo With Same Dosing Schedule as the Active Comparator Arm
n=6 Participants
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Total Morphine Equivalent
Day 1
|
28.9 mg
Standard Error 11.6
|
55.0 mg
Standard Error 14.2
|
|
Total Morphine Equivalent
Average, days 2 to 4
|
30.4 mg
Standard Error 9.6
|
72.4 mg
Standard Error 11.7
|
|
Total Morphine Equivalent
Average, days 5 to 7
|
27.8 mg
Standard Error 9.6
|
69.7 mg
Standard Error 11.7
|
|
Total Morphine Equivalent
Average, days 8 to 10
|
13.2 mg
Standard Error 9.6
|
38.3 mg
Standard Error 11.7
|
Adverse Events
Celecoxib as Experimerimental Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Control, Active Comparator
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Celecoxib as Experimerimental Intervention
n=9 participants at risk
Celecoxib 200 mg tablets
Celecoxib: Celecoxib 200 mg capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
Placebo Control, Active Comparator
n=6 participants at risk
Placebo with same dosing schedule as the active comparator arm
Placebo: Placebo capsule
1. capsule the night before surgery
2. capsules the morning of surgery
1 capsule the night of surgery
1 capsule twice daily for 10 days immediately after the surgery
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting, grade 1
|
11.1%
1/9 • Number of events 5 • 3 weeks postoperatively
|
33.3%
2/6 • Number of events 2 • 3 weeks postoperatively
|
|
Metabolism and nutrition disorders
Dehydration, grade 2
|
0.00%
0/9 • 3 weeks postoperatively
|
33.3%
2/6 • Number of events 2 • 3 weeks postoperatively
|
|
Gastrointestinal disorders
Dysphagia, grade 2
|
0.00%
0/9 • 3 weeks postoperatively
|
16.7%
1/6 • Number of events 1 • 3 weeks postoperatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place