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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.
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.
Age
5 - 9 years
Sex
ALL
Healthy Volunteers
No
Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States
Start Date
April 15, 2019
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2026
Last Updated
January 16, 2026
160
ESTIMATED participants
Hydrocodone/acetaminophen
DRUG
Acetaminophen
DRUG
Ibuprofen
DRUG
Lead Sponsor
Children's Mercy Hospital Kansas City
NCT03759028
NCT05780398
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02196311