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

January 8, 2024 updated by: Lisa Berglund, Children's Mercy Hospital Kansas City

Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group (opioid group)
Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN
Drug: Hydrocodone/acetaminophen
Hydrocodone/acetaminophen 0.15mg/kg PO q6
Drug: Ibuprofen
10mg/kg PO q6 hours
Experimental: Experimental Group (nonopioid group):
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours
Drug: Ibuprofen
10mg/kg PO q6 hours
Drug: Acetaminophen
15mg/kg PO q6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome will be subject reported pain level using the Wong-Baker Faces Pain Scale.
Time Frame: At the relative same time each day on postoperative days 1-5 (i.e., five follow-up measures).
The subject reported pain level using the scale 0-10, will be measured at the time of discharge (i.e., baseline measure).
At the relative same time each day on postoperative days 1-5 (i.e., five follow-up measures).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent satisfaction with (subject) child's pain control
Time Frame: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention
Using the Likert scale, "very dissatisfied, dissatisfied, neutral, satisfied, very satisfied" options, the investigators ask families to rate the satisfaction of their child's pain control daily for 5 days.
Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000286

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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