Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Baylor College of Medicine

Status and phase: Invitation-only; Phase 4

Conditions: Supracondylar Humerus Fracture

Treatments: Drug: Ibuprofen; Drug: Acetaminophen; Drug: Hydrocodone/acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT05640674

52475

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Opioid Pain Management

Active Comparator group

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.

Treatment:

Drug: Hydrocodone/acetaminophen

Drug: Ibuprofen

Non-Opioid Pain Management

Experimental group

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.

Treatment:

Drug: Acetaminophen

Drug: Ibuprofen