Trial Outcomes & Findings for Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients (NCT NCT04541147)
NCT ID: NCT04541147
Last Updated: 2024-12-27
Results Overview
Measured by medication log and units remaining.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
4 weeks post-op
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Dexamethasone Plus Analgesics
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Dexamethasone Plus Analgesics
n=16 Participants
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
n=8 Participants
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
7.8 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
8.5 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-opPopulation: Participants who completed the study.
Measured by medication log and units remaining.
Outcome measures
| Measure |
Dexamethasone Plus Analgesics
n=14 Participants
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
n=7 Participants
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
|---|---|---|
|
Opioid Use (Number of Doses)
|
11.5 doses
Standard Deviation 10.8
|
18.4 doses
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: 14 days post-opPopulation: Participants who completed the study.
Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
Outcome measures
| Measure |
Dexamethasone Plus Analgesics
n=14 Participants
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
n=7 Participants
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
|---|---|---|
|
Average Pain Score
|
3.1 score on a scale
Standard Deviation 1.7
|
2.7 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 30 days post-opPopulation: Participants who completed the study.
Post-op re-admissions and emergency room visits.
Outcome measures
| Measure |
Dexamethasone Plus Analgesics
n=14 Participants
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
n=7 Participants
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
|---|---|---|
|
Number of Participants With Post-operative Complications
|
1 Participants
|
1 Participants
|
Adverse Events
Dexamethasone Plus Analgesics
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Analgesics Alone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexamethasone Plus Analgesics
n=16 participants at risk
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
Dexamethasone: dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
Analgesics Alone
n=8 participants at risk
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
Analgesics: standardization of post-operative analgesics (narcotics and non-narcotic medication).
* Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
* Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
* Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)
|
|---|---|---|
|
General disorders
Emergency Room Visit
|
6.2%
1/16 • Up to 30 days post-op
|
12.5%
1/8 • Up to 30 days post-op
|
|
Injury, poisoning and procedural complications
Bleeding
|
12.5%
2/16 • Up to 30 days post-op
|
12.5%
1/8 • Up to 30 days post-op
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
31.2%
5/16 • Up to 30 days post-op
|
37.5%
3/8 • Up to 30 days post-op
|
|
General disorders
Sleep Disturbance/Insomnia
|
68.8%
11/16 • Up to 30 days post-op
|
62.5%
5/8 • Up to 30 days post-op
|
|
General disorders
Fever
|
12.5%
2/16 • Up to 30 days post-op
|
12.5%
1/8 • Up to 30 days post-op
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Up to 30 days post-op
|
12.5%
1/8 • Up to 30 days post-op
|
|
General disorders
Other - not specified
|
0.00%
0/16 • Up to 30 days post-op
|
12.5%
1/8 • Up to 30 days post-op
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place