Trial Outcomes & Findings for Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management (NCT NCT06187584)
NCT ID: NCT06187584
Last Updated: 2026-03-31
Results Overview
The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome.
COMPLETED
PHASE4
137 participants
At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).
2026-03-31
Participant Flow
Participant milestones
| Measure |
Control Group (Opioid Group)
Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
Experimental Group (Nonopioid Group):
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
45
|
|
Overall Study
COMPLETED
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control Group (Opioid Group)
Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
Experimental Group (Nonopioid Group):
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
Baseline characteristics by cohort
| Measure |
Control Group (Opioid Group)
n=41 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
Experimental Group (Nonopioid Group):
n=44 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
41 Participants
n=4 Participants
|
44 Participants
n=28 Participants
|
85 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
75.79 Months
STANDARD_DEVIATION 13.59 • n=4 Participants
|
74.97 Months
STANDARD_DEVIATION 16.76 • n=28 Participants
|
75.10 Months
STANDARD_DEVIATION 15.34 • n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=4 Participants
|
23 Participants
n=28 Participants
|
40 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=4 Participants
|
21 Participants
n=28 Participants
|
45 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=4 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=4 Participants
|
5 Participants
n=28 Participants
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=4 Participants
|
29 Participants
n=28 Participants
|
62 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=4 Participants
|
2 Participants
n=28 Participants
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=4 Participants
|
7 Participants
n=28 Participants
|
8 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=4 Participants
|
44 Participants
n=28 Participants
|
85 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).Population: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future.
The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=44 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=41 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Discharge pain level (baseline)
|
4.46 units on a scale
Standard Deviation 2.55
|
4.10 units on a scale
Standard Deviation 2.05
|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Post-operative Day 1 Pain Level
|
3.4 units on a scale
Standard Deviation 2.53
|
3.82 units on a scale
Standard Deviation 2.43
|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Post-operative Day 2 Pain Level
|
2.85 units on a scale
Standard Deviation 2.06
|
2.8 units on a scale
Standard Deviation 2.14
|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Post-operative Day 3 Pain Level
|
1.44 units on a scale
Standard Deviation 1.54
|
2.28 units on a scale
Standard Deviation 2.19
|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Post-operative Day 4 Pain Level
|
1.59 units on a scale
Standard Deviation 1.55
|
1.71 units on a scale
Standard Deviation 1.51
|
|
Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Post-operative Day 5 Pain Level
|
1.29 units on a scale
Standard Deviation 1.32
|
1.36 units on a scale
Standard Deviation 1.45
|
SECONDARY outcome
Timeframe: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post interventionPopulation: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. For each post-operative day, not all of the participants filled out the survey every single day, thus the numbers vary by day.
Using the Likert scale 1-5, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators asked families to rate the satisfaction of their child's pain control daily for 5 days. The higher the number, the higher the satisfaction.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=44 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=41 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Parent Satisfaction With (Subject) Child's Pain Control
Post op day 1 satisfaction level
|
3.83 units on a scale
Standard Deviation 1.18
|
3.71 units on a scale
Standard Deviation 1.34
|
|
Parent Satisfaction With (Subject) Child's Pain Control
Post op day 2 satisfaction level
|
3.97 units on a scale
Standard Deviation 1.05
|
4.13 units on a scale
Standard Deviation 0.82
|
|
Parent Satisfaction With (Subject) Child's Pain Control
Post op day 3 satisfaction level
|
4.47 units on a scale
Standard Deviation 0.72
|
4.38 units on a scale
Standard Deviation 0.62
|
|
Parent Satisfaction With (Subject) Child's Pain Control
Post op day 4 satisfaction level
|
4.66 units on a scale
Standard Deviation 0.61
|
4.46 units on a scale
Standard Deviation 0.58
|
|
Parent Satisfaction With (Subject) Child's Pain Control
Post op day 5 satisfaction level
|
4.65 units on a scale
Standard Deviation 0.66
|
4.54 units on a scale
Standard Deviation 0.51
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future.
Participants' parent completed a survey asking the number of days of medication use
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Number of Days of Medication Usage
|
4.65 number of days
Standard Deviation 2.61
|
2.48 number of days
Standard Deviation 2.47
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Number of participants analyzed is lower than enrollment number because not all participants filled out a survey at their 1st follow up visit. Count of participants in the Outcome Measure Data Table is count of how many answered "yes" to side effects.
Participant completed a Yes/No survey asking if they experienced any of the following: Nausea, Vomiting, Constipation, Headache, Dizziness, Drowsiness, Rash, Other.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Side Effects From Medication
|
4 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants answered "yes".
Participant completed a Yes/No survey asking if use of medication other than those indicated by their physician to control pain occured.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain
Count of participants who took other medication in addition to prescribed medication
|
0 Participants
|
0 Participants
|
|
Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain
Count of participants who took other medication instead of prescribed medication
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants called provider for pain rescue.
Participant completed a survey asking for numerical count of phone calls for pain rescue.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue
Count of participants who called once
|
1 Participants
|
2 Participants
|
|
Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue
Count of participant who called more than once
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants answered "yes".
Participant completed survey asking for count of visits for pain rescue.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue
|
0 Number of visits
|
0 Number of visits
|
SECONDARY outcome
Timeframe: Postoperative days 1-5Population: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future.
Survey for number of doses taken by participant each postoperative day 1-5
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=44 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=41 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Post op Day 1 Number of medication doses
|
2.67 medication doses
Standard Deviation 1.47
|
1.38 medication doses
Standard Deviation 1.34
|
|
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Post op Day 2 Number of medication doses
|
2.23 medication doses
Standard Deviation 1.45
|
1.25 medication doses
Standard Deviation 1.54
|
|
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Post op Day 3 Number of medication doses
|
1.67 medication doses
Standard Deviation 1.42
|
0.53 medication doses
Standard Deviation 1.02
|
|
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Post op Day 4 Number of medication doses
|
1.19 medication doses
Standard Deviation 1.47
|
0.32 medication doses
Standard Deviation 0.61
|
|
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Post op Day 5 Number of medication doses
|
0.93 medication doses
Standard Deviation 1.22
|
0.16 medication doses
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future.
Participant completed survey using 5 point Likert scale "very poorly", "poorly", "neutral", "well", "very well". Very poorly = 1, Poorly = 2, Neutral = 3, Well = 4, Very well = 5
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Participant's Overall Pain Control
|
4.19 units on a scale
Standard Deviation 1.06
|
4.56 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: First follow up visit, occurring approximately one week postoperatively.Population: Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future.
Using the Likert scale, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators ask families to rate overall their satisfaction with their child's pain control in the first five days after surgery.
Outcome measures
| Measure |
Experimental Group (Nonopioid Group):
n=26 Participants
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Acetaminophen: 15mg/kg PO q6 hours
Ibuprofen: 10mg/kg PO q6 hours
|
Control Group (Opioid Group)
n=27 Participants
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6
Ibuprofen: 10mg/kg PO q6 hours
|
|---|---|---|
|
Overall Parent Satisfaction
|
4.35 units on a scale
Standard Deviation 0.98
|
4.67 units on a scale
Standard Deviation 0.48
|
Adverse Events
Control Group (Opioid Group)
Experimental Group (Nonopioid Group):
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place