Trial Outcomes & Findings for Management of Post-Tonsillectomy Pain in Pediatric Patients (NCT NCT04551196)
NCT ID: NCT04551196
Last Updated: 2024-07-11
Results Overview
The proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
COMPLETED
PHASE3
50 participants
up to 3 days following consent
2024-07-11
Participant Flow
Eligible candidates scheduled to undergo tonsillectomy at SLCH were approached either in the outpatient setting or preoperative holding area prior to surgery by the study team. Recruitment period was from 3/2020 - 10/2021.
Participant milestones
| Measure |
Alternating Regimen
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Post-Tonsillectomy Pain in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 3 days following consentThe proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 from POD 1 through POD 3 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 3
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 separate individual days, will be completed days after the surgeryThe proportion of FLACC (Faces, Legs, Activity, Cry, and Consolability scale) pain scores ≥7 on each individual POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With FLACC Pain Scores ≥7 on Each Individual POD 1, 3, and 7
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 7 days following consentThe proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The FLACC scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria (Faces, Legs, Activity, Cry, and Consolability), which are each assigned a score of 0, 1 or 2.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With FLACC Pain Scores ≥7 From POD 1 Through POD 7
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 3 separate individual days, will be completed days after the surgeryThe proportion of Faces pain scores ≥8 on POD 1, 3, and 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With Faces Pain Scores ≥8 on POD 1, 3, and 7
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 7 days following consentThe proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7 compared between the combined and the alternating medication regimens. The Faces scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With Cumulative Faces Pain Scores ≥8 From POD 1 Through POD 7
|
3 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 3 days following consentThe proportion of rescue medication usage from POD 1 through POD 3 compared between the combined and the alternating medication regimens.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With Rescue Medication Usage Through POD 3
|
3 participants
|
7 participants
|
SECONDARY outcome
Timeframe: up to 7 days following consentThe proportion of rescue medication usage from POD 1 through POD 7 compared between the combined and the alternating medication regimens.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Number of Participants With Rescue Medication Usage Through POD 7
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: up to 3 days following consentProportion of subjects that adhere to the assigned medication regimen compared between the combined and the alternating medication regimens as determined by the medication log that the participants return at the end of the study.
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Proportion of Subjects That Adhere to the Assigned Medication Regimen
|
25 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: up to 7 days following consentPopulation: Alternating regimen
Incidence of adverse events
Outcome measures
| Measure |
Alternating Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 Participants
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Adverse Events
|
3 participants
|
3 participants
|
Adverse Events
Alternating Regimen
Combined Regimen
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alternating Regimen
n=25 participants at risk
A regimen of acetaminophen and ibuprofen alternating doses every 3 hours.
Alternating Acetaminophen and Ibuprofen: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
|
Combined Regimen
n=25 participants at risk
A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Combined Acetaminophen and Ibuprofen: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Number of events 2 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
|
Gastrointestinal disorders
Emesis
|
12.0%
3/25 • Number of events 3 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
|
Gastrointestinal disorders
Bloody Oral Secretions
|
0.00%
0/25 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
|
General disorders
Pain - Uncontrolled
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
4.0%
1/25 • Number of events 1 • Adverse event data was collected post operatively days 1 through 7
Follow up surveys to assess pain scores and adverse events were sent to participants twice a day on post-operative day (POD) 1, 3, and 7.
|
Additional Information
David Leonard, MD, Principal Investigator
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place