Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Supracondylar Humerus Fracture Clinical Trial

Official title:

A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05640674
• Other study ID #: 52475
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: September 12, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Drug:
• Ibuprofen
Non-opioid
• Hydrocodone/acetaminophen
Opioid
• Acetaminophen
Non-opioid

Locations

Country	Name	City	State
United States	Texas Children's Hospital - Main Campus	Houston	Texas
United States	Texas Children's Hospital - West Campus	Houston	Texas
United States	Texas Children's Hospital - Woodlands Campus	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	from discharge until pain medication is no longer required (assessed up to 3 weeks)
Secondary	Number of Pain Medication Doses Required per Day	A parent/guardian will record the doses of pain medications given to the participant each day.	from discharge until pain medication is no longer required (assessed up to 3 weeks)
Secondary	Number of Days Pain Medication Required	A parent/guardian will record the doses of pain medications given to the participant each day.	from discharge until pain medication is no longer required (assessed up to 3 weeks)