Trial Outcomes & Findings for Pediatric Pain Optimization After Tonsillectomy (NCT NCT05244226)
NCT ID: NCT05244226
Last Updated: 2024-10-17
Results Overview
Postoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Up to 7 days post surgery
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone 0.1mg/kg
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone 0.15mg/kg
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone 0.1mg/kg
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone 0.15mg/kg
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
2
|
Baseline Characteristics
Pediatric Pain Optimization After Tonsillectomy
Baseline characteristics by cohort
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=20 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone 0.1mg/kg
n=20 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone 0.15mg/kg
n=20 Participants
High dose methadone: 0.15mg/kg
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
4.0 years
n=5 Participants
|
4.5 years
n=7 Participants
|
4.5 years
n=5 Participants
|
4.3 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 7 days post surgeryPostoperative opioid medication expressed in oral morphine equivalents (OME) per kilogram
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=20 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=20 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=20 Participants
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Total Amount of Opioid Medications Administered
|
1.5 morphine mg equivalents/kg
Interval 1.2 to 2.1
|
0.9 morphine mg equivalents/kg
Interval 0.1 to 1.4
|
0.5 morphine mg equivalents/kg
Interval 0.0 to 1.4
|
SECONDARY outcome
Timeframe: Up to 7 days post surgeryPopulation: Participants who were less than 13 years of age. Each participant reported 7 scores.
The PPPM has 15 yes/no questions which results in a score from 0-15, where a higher score indicates greater pain. A score of at least 6 out of 15 signifies clinically significant pain. The percentage of scores \> or = 6 is shown below.
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=133 PPPM scores
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=126 PPPM scores
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=126 PPPM scores
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Percentage of Scores on the Parent Post Operative Pain Measure (PPPM) That Indicate Clinically Significant Pain
|
57 percentage of PPPM scores
|
61 percentage of PPPM scores
|
63 percentage of PPPM scores
|
SECONDARY outcome
Timeframe: Up to 7 days post surgeryPopulation: Participants who were less than 13 years of age.
Patient caregiver (as proxy) pain scores over past 7 days. Scale of 1 to 6, where 1=had no pain and 6=almost always had pain.
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=19 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=18 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=18 Participants
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) Parent Proxy Report Scale
|
2.4 score on a scale
Standard Deviation 1.5
|
2.2 score on a scale
Standard Deviation 1.2
|
2.3 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Up to 7 days post surgeryNumeric Pain Rating Scale has a range of 0 to 10, where 0=no pain and 10=worst possible pain.
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=20 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=20 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=20 Participants
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Evaluation of Participant's Pain as Measured by Numeric Pain Rating Scale
|
4.0 score on a scale
Standard Deviation 2.5
|
3.7 score on a scale
Standard Deviation 1.9
|
3.8 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Up to 7 days post surgeryNumber of doses of prescription medication used.
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=20 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=20 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=20 Participants
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Doses of Prescription Opioid Used Following Hospital Discharge
|
4 doses
Interval 3.0 to 9.0
|
2 doses
Interval 0.0 to 4.0
|
3 doses
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Up to 6 hours post surgeryOpioid medication use in the recovery room expressed in oral morphine equivalents (OME) per kilogram.
Outcome measures
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=20 Participants
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=20 Participants
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=20 Participants
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Opioid Administration in the PACU (Post-anesthesia Care Unit)
|
0.15 morphine mg equivalents/kg
Interval 0.1 to 0.3
|
0.04 morphine mg equivalents/kg
Interval 0.0 to 0.1
|
0 morphine mg equivalents/kg
Interval 0.0 to 0.1
|
Adverse Events
Short Acting Opioids: Fentanyl, Hydromorphone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Acting Opioid: Methadone (0.1mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Long Acting Opioid: Methadone (0.15mg/kg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Short Acting Opioids: Fentanyl, Hydromorphone
n=21 participants at risk
Fentanyl/Hydromorphone: Per routine care
|
Long Acting Opioid: Methadone (0.1mg/kg)
n=22 participants at risk
Low dose methadone: 0.1mg/kg
|
Long Acting Opioid: Methadone (0.15mg/kg)
n=23 participants at risk
High dose methadone: 0.15 mg/kg
|
|---|---|---|---|
|
Nervous system disorders
Altered mental status
|
4.8%
1/21 • 30 days
|
0.00%
0/22 • 30 days
|
0.00%
0/23 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place