Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2025-12-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Supracondylar Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

Non-opioid

Hydrocodone/acetaminophen

Intervention Type DRUG

Opioid

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.

Group Type EXPERIMENTAL

Ibuprofen

Intervention Type DRUG

Non-opioid

Acetaminophen

Intervention Type DRUG

Non-opioid

Interventions

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Ibuprofen

Non-opioid

Intervention Type DRUG

Hydrocodone/acetaminophen

Opioid

Intervention Type DRUG

Acetaminophen

Non-opioid

Intervention Type DRUG

Other Intervention Names

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Motrin, Advil Hycet Tylenol

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No