Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Sponsor

Baylor College of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640674

Collaborator

(none)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

33.3

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Supracondylar Humerus Fracture	Drug: Ibuprofen Drug: Hydrocodone/acetaminophen Drug: Acetaminophen	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Ibuprofen Non-opioid Other Names: Motrin, Advil Drug: Hydrocodone/acetaminophen Opioid Other Names: Hycet
Experimental: 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.	Drug: Ibuprofen Non-opioid Other Names: Motrin, Advil Drug: Acetaminophen Non-opioid Other Names: Tylenol

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Ibuprofen

Non-opioid

Other Names:

Motrin, Advil

Drug: Hydrocodone/acetaminophen

Opioid

Other Names:

Hycet

Experimental: 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.

Drug: Ibuprofen

Non-opioid

Other Names:

Motrin, Advil

Drug: Acetaminophen

Non-opioid

Other Names:

Tylenol

Outcome Measures

Primary Outcome Measures

Daily Pain Scores on the FACES Scale [from discharge until pain medication is no longer required (assessed up to 3 weeks)]
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 [from discharge until pain medication is no longer required (assessed up to 3 weeks)]
A parent/guardian will record the doses of pain medications given to the participant each day.
Number of Days Pain Medication Required [from discharge until pain medication is no longer required (assessed up to 3 weeks)]
A parent/guardian will record the doses of pain medications given to the participant each day.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Closed supracondylar humerus fracture (Gartland type II or III)
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Children's Hospital - Main Campus	Houston	Texas	United States	77030
2	Texas Children's Hospital - West Campus	Houston	Texas	United States	77094
3	Texas Children's Hospital - Woodlands Campus	Houston	Texas	United States	77384