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Trial Outcomes & Findings for Post-operative Pain Management in Children With Supracondylar Humerus Fractures (NCT NCT05640674)

NCT ID: NCT05640674

Last Updated: 2026-02-10

Results Overview

A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain).

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

from discharge until pain medication is no longer required (assessed up to 3 weeks)

Results posted on

2026-02-10

Participant Flow

Participant milestones

Participant milestones
Measure
Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Overall Study
STARTED
14
15
Overall Study
COMPLETED
8
5
Overall Study
NOT COMPLETED
6
10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Opioid Pain Management
n=14 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management
n=15 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Total
n=29 Participants
Total of all reporting groups
Age, Continuous
6.6 Years
STANDARD_DEVIATION 2.2 • n=4 Participants
6.4 Years
STANDARD_DEVIATION 1.3 • n=4 Participants
6.5 Years
STANDARD_DEVIATION 1.8 • n=8 Participants
Sex: Female, Male
Female
13 Participants
n=4 Participants
5 Participants
n=4 Participants
18 Participants
n=8 Participants
Sex: Female, Male
Male
1 Participants
n=4 Participants
10 Participants
n=4 Participants
11 Participants
n=8 Participants
Race/Ethnicity, Customized
White
10 Participants
n=4 Participants
6 Participants
n=4 Participants
16 Participants
n=8 Participants
Race/Ethnicity, Customized
Black
1 Participants
n=4 Participants
1 Participants
n=4 Participants
2 Participants
n=8 Participants
Race/Ethnicity, Customized
Hispanic
3 Participants
n=4 Participants
7 Participants
n=4 Participants
10 Participants
n=8 Participants
Race/Ethnicity, Customized
Unknown
0 Participants
n=4 Participants
1 Participants
n=4 Participants
1 Participants
n=8 Participants

PRIMARY outcome

Timeframe: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Population: Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed.

A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome measures
Measure
Opioid Pain Management
n=8 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management
n=5 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Daily Pain Scores on the FACES Scale
2.7 scores on a scale/day
Standard Deviation 3.0
1.31 scores on a scale/day
Standard Deviation 1.9

SECONDARY outcome

Timeframe: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Population: Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed.

A parent/guardian will record the doses of pain medications given to the participant each day.

Outcome measures

Outcome measures
Measure
Opioid Pain Management
n=8 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management
n=5 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Number of Days Pain Medication Required
12.5 days
Standard Deviation 7.13
6.2 days
Standard Deviation 2.49

SECONDARY outcome

Timeframe: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Population: Only 8 opioid and 5 non-opioid patients completed the pain journal, so they are the only patients who could be analyzed.

A parent/guardian will record the doses of pain medications given to the participant each day.

Outcome measures

Outcome measures
Measure
Opioid Pain Management
n=8 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management
n=5 Participants
Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Number of Pain Medication Doses Required Per Day
1.49 doses of medication/day
Standard Deviation 0.5
1.42 doses of medication/day
Standard Deviation 0.56

Adverse Events

Opioid Pain Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-Opioid Pain Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

SCOTT ROSENFELD, MD

Baylor College of Medicine/ Texas Children's Hospital

Phone: 832-824-1000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place