SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management

Children's Mercy Hospital Kansas City

Status and phase: Invitation-only; Phase 4

Conditions: Supracondylar Humerus Fracture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06187584

STUDY00000286

Details and patient eligibility

About

This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.

Full description

Pain is variably managed in pediatric populations, particularly in the postoperative outpatient setting. The lack of data describing and supporting the safety and efficacy of the use of analgesic drugs in children is a major contributor to this problem. Postoperative prescription opioids have been associated with high rates of morbidity and mortality in children and identified as a pathway to future opioid abuse. With increasing public awareness regarding these issues surrounding opioid use and no evidence to support superior treatment outcomes in children with the use of opioids, there is a pressing need for data to guide healthcare providers in choosing analgesic drugs to treat postoperative pain in pediatric patients.

Prior studies have evaluated the use of nonopioid versus opioid analgesic drugs in the outpatient setting following pediatric ambulatory surgery. These studies found nonopioid analgesics, such as acetaminophen and ibuprofen, to be as equally effective as opioid analgesics, including morphine, codeine and oxycodone. Further, the use of nonopioid analgesics was associated with significantly fewer side effects. These findings imply that nonopioid analgesics may be a superior initial therapy following ambulatory surgery.

However, no study has evaluated the use of nonopioid versus opioid analgesic regimens in the outpatient setting following surgical fixation of supracondylar humerus fractures (SCHFS). SCHFs are the second most common fracture in children, often requiring urgent surgical intervention. Despite their frequency, there is no standard for postoperative outpatient pain management in the treatment of these injuries.

Almost all SCHFs can be described according to the Gartland classification. The Gartland classification delineates three types of SCHFs. Gartland type I fractures are nondisplaced and do not require surgical intervention, while Gartland type II fractures are angulated, but maintain an intact posterior cortex. These may or may not require surgical intervention. However, Gartland type III fractures are completely displaced with no posterior cortical contact and require surgical intervention with either closed reduction and percutaneous pinning (CRPP) or open reduction with percutaneous pinning (ORPP). This study will look at only Gartland type III SCHFs because they necessitate surgical intervention, most commonly CRPP.

Investigators hypothesize that there is no difference in daily pain levels for nonopioid analgesic regimens compared to opioid analgesic regimens in management of post-operative pain in the outpatient period following surgical fixation of Gartland type III supracondylar humerus fracture in children.

Enrollment: 160 estimated patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting to Children's Mercy Hospital
• Patients 48-119 months of age
• Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: S42.411A, S42.412A and S42.413A)

Exclusion criteria

• Patients younger than 48 months of age or older than 120 months of age
• Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-)
• Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, S42.412B and S42.413B)
• Injury requiring open reduction and/or vascular injury requiring treatment
• Patients presenting with additional injuries
• Patients with known allergy to medications used in this study
• Patients receiving regular treatment with opioids or NSAIDs
• Patients with underlying medical issues affecting cognitive status
• Patients with hepatic, gastrointestinal, renal or hematologic disease/disorders
• Children that are wards of the state, prisoners or of CM employees
• Non-English speaking families
• Patients not admitted before and after surgery
• Fractures not surgically treated within 18 hours of injury
• Use of local anesthetic at surgical site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Control Group (opioid group)

Active Comparator group

Description:

Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN

Treatment:

Drug: Hydrocodone/acetaminophen

Drug: Ibuprofen

Experimental Group (nonopioid group):

Experimental group

Description:

Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

Treatment:

Drug: Ibuprofen

Drug: Acetaminophen