Trial Outcomes & Findings for Celecoxib After Tonsillectomy (NCT NCT02934191)
NCT ID: NCT02934191
Last Updated: 2020-03-10
Results Overview
The number of days on narcotic pain medication following surgery will be compared between the two treatment groups
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
2 weeks post-operative
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Acetaminophen/Oxycodone + Celecoxib
Subjects will take acetaminophen orally in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally.
|
Acetaminophen/Oxycodone + Placebo
Subjects will take acetaminophen orally in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
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|---|---|---|
|
Overall Study
STARTED
|
87
|
85
|
|
Overall Study
COMPLETED
|
87
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acetaminophen/Oxycodone + Celecoxib
n=87 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
|
Acetaminophen/Oxycodone + Placebo
n=85 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.27 years
n=87 Participants
|
5.72 years
n=85 Participants
|
6.03 years
n=172 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=87 Participants
|
46 Participants
n=85 Participants
|
95 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=87 Participants
|
39 Participants
n=85 Participants
|
77 Participants
n=172 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
87 Participants
n=87 Participants
|
85 Participants
n=85 Participants
|
172 Participants
n=172 Participants
|
PRIMARY outcome
Timeframe: 2 weeks post-operativePopulation: Subjects with evaluable data
The number of days on narcotic pain medication following surgery will be compared between the two treatment groups
Outcome measures
| Measure |
Acetaminophen/Oxycodone + Celecoxib
n=73 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
|
Acetaminophen/Oxycodone + Placebo
n=67 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
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|---|---|---|
|
Difference in Number of Days Requiring Rescue Pain Medication
|
5.00 Days
Standard Deviation 3.35
|
5.75 Days
Standard Deviation 3.82
|
PRIMARY outcome
Timeframe: 2 weeks post-operativePopulation: Subjects with evaluable data
The total amount of rescue pain medication consumed in the 2-week postop period will be compared between the two treatment groups.
Outcome measures
| Measure |
Acetaminophen/Oxycodone + Celecoxib
n=73 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
|
Acetaminophen/Oxycodone + Placebo
n=67 Participants
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
|
|---|---|---|
|
Difference in Amount of Rescue Pain Medication Consumed
|
1.03 mg/kg
Standard Deviation 1.12
|
1.40 mg/kg
Standard Deviation 1.45
|
Adverse Events
Acetaminophen/Oxycodone + Celecoxib
Serious events: 9 serious events
Other events: 78 other events
Deaths: 0 deaths
Acetaminophen/Oxycodone + Placebo
Serious events: 7 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Acetaminophen/Oxycodone + Celecoxib
n=87 participants at risk
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
|
Acetaminophen/Oxycodone + Placebo
n=85 participants at risk
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Hemorrhage
|
3.4%
3/87 • Number of events 3 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
7.1%
6/85 • Number of events 6 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
General disorders
Dehydration
|
4.6%
4/87 • Number of events 4 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
1.2%
1/85 • Number of events 1 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Infections and infestations
Dental infection
|
1.1%
1/87 • Number of events 1 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
0.00%
0/85 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.1%
1/87 • Number of events 1 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
0.00%
0/85 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
Other adverse events
| Measure |
Acetaminophen/Oxycodone + Celecoxib
n=87 participants at risk
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take celecoxib orally (dose is 6mg/kg twice a day with a maximum dose of 300mg twice a day). The first dose of celecoxib will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Celecoxib: Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
|
Acetaminophen/Oxycodone + Placebo
n=85 participants at risk
Subjects will take acetaminophen orally (dose 15mg/kg/dose) in scheduled doses every 4 hours for the first 5 days. Subjects will also take the placebo orally twice a day. The first dose of placebo will be given preoperatively, within 1 hour prior to entering the operating room. The second dose will be given at bedtime on the night of surgery and subsequent doses will be given 12 hours apart. Supplemental standard of care oxycodone may be used to control breakthrough pain.
Placebo: Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea / Vomiting
|
21.8%
19/87 • Number of events 19 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
11.8%
10/85 • Number of events 10 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Gastrointestinal disorders
Abdominal Pain
|
35.6%
31/87 • Number of events 31 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
30.6%
26/85 • Number of events 26 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Gastrointestinal disorders
constipation
|
1.1%
1/87 • Number of events 1 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
2.4%
2/85 • Number of events 2 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Gastrointestinal disorders
Diarrhea
|
10.3%
9/87 • Number of events 9 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
3.5%
3/85 • Number of events 3 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
General disorders
Headache
|
12.6%
11/87 • Number of events 11 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
4.7%
4/85 • Number of events 4 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
3/87 • Number of events 3 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
1.2%
1/85 • Number of events 1 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
|
Ear and labyrinth disorders
Dizziness
|
4.6%
4/87 • Number of events 4 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
4.7%
4/85 • Number of events 4 • 30 days
Adverse events were collected for the 30 day postoperative period, and were collected systematically from the day 3, day 14, day 30 telephone calls, and the Study Diary
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place