Back to resultsPost-operative Pain Management in Children With Supracondylar Humerus Fractures
Primary Purpose
Supracondylar Humerus Fracture
Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Hydrocodone/acetaminophen
Acetaminophen
Sponsored by
About this trial
This is an interventional supportive care trial for Supracondylar Humerus Fracture
Eligibility Criteria
Inclusion Criteria: Closed, Gartland type III supracondylar humerus fracture Fractures treated with closed reduction and percutaneous pinning (CRPP) Patients expected to follow up at Texas Children's Hospital Patients/guardians must speak English or Spanish Exclusion Criteria: Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit Patients who have impaired ability to report pain severity such as intellectual delay. Patients who have a problem with bone healing such as osteogenesis imperfecta. Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc). Patients who are on chronic NSAID or opioid medication prior to injury. Patients with injury from suspected non-accidental trauma.
Sites / Locations
- Texas Children's Hospital - Main Campus
- Texas Children's Hospital - West Campus
- Texas Children's Hospital - Woodlands Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Opioid Pain Management
Non-Opioid Pain Management
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Daily Pain Scores on the FACES Scale
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).
Secondary Outcome Measures
Number of Pain Medication Doses Required per Day
A parent/guardian will record the doses of pain medications given to the participant each day.
Number of Days Pain Medication Required
A parent/guardian will record the doses of pain medications given to the participant each day.
Full Information
NCT ID
NCT05640674
First Posted
November 29, 2022
Last Updated
September 12, 2023
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05640674
Brief Title
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
Official Title
A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.
Detailed Description
Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supracondylar Humerus Fracture
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Opioid Pain Management
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-Opioid Pain Management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Motrin, Advil
Intervention Description
Non-opioid
Intervention Type
Drug
Intervention Name(s)
Hydrocodone/acetaminophen
Other Intervention Name(s)
Hycet
Intervention Description
Opioid
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
Non-opioid
Primary Outcome Measure Information:
Title
Daily Pain Scores on the FACES Scale
Description
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).
Time Frame
from discharge until pain medication is no longer required (assessed up to 3 weeks)
Secondary Outcome Measure Information:
Title
Number of Pain Medication Doses Required per Day
Description
A parent/guardian will record the doses of pain medications given to the participant each day.
Time Frame
from discharge until pain medication is no longer required (assessed up to 3 weeks)
Title
Number of Days Pain Medication Required
Description
A parent/guardian will record the doses of pain medications given to the participant each day.
Time Frame
from discharge until pain medication is no longer required (assessed up to 3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Closed, Gartland type III supracondylar humerus fracture
Fractures treated with closed reduction and percutaneous pinning (CRPP)
Patients expected to follow up at Texas Children's Hospital
Patients/guardians must speak English or Spanish
Exclusion Criteria:
Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit
Patients who have impaired ability to report pain severity such as intellectual delay.
Patients who have a problem with bone healing such as osteogenesis imperfecta.
Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc).
Patients who are on chronic NSAID or opioid medication prior to injury.
Patients with injury from suspected non-accidental trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Rosenfeld, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital - Main Campus
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital - West Campus
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Facility Name
Texas Children's Hospital - Woodlands Campus
City
Houston
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
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