Skip to main content
OpenTrials
Completed

NCT Number: NCT06187584

Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Mercy Hospital & Clinics

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocodone/Acetaminophen

Drug

Hydrocodone/acetaminophen 0.15mg/kg PO q6

Acetaminophen

Drug

15mg/kg PO q6 hours

Ibuprofen

Drug

10mg/kg PO q6 hours

Primary outcomes

  1. Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.

    Time frame: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).

    The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome.

Secondary outcomes

  1. 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 1-5, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators asked families to rate the satisfaction of their child's pain control daily for 5 days. The higher the number, the higher the satisfaction.

  2. Number of Days of Medication Usage

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participants' parent completed a survey asking the number of days of medication use

  3. Side Effects From Medication

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participant completed a Yes/No survey asking if they experienced any of the following: Nausea, Vomiting, Constipation, Headache, Dizziness, Drowsiness, Rash, Other.

  4. Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participant completed a Yes/No survey asking if use of medication other than those indicated by their physician to control pain occured.

  5. Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participant completed a survey asking for numerical count of phone calls for pain rescue.

  6. Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participant completed survey asking for count of visits for pain rescue.

  7. Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5

    Time frame: Postoperative days 1-5

    Survey for number of doses taken by participant each postoperative day 1-5

  8. Participant's Overall Pain Control

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Participant completed survey using 5 point Likert scale "very poorly", "poorly", "neutral", "well", "very well".

    Very poorly = 1, Poorly = 2, Neutral = 3, Well = 4, Very well = 5

  9. Overall Parent Satisfaction

    Time frame: First follow up visit, occurring approximately one week postoperatively.

    Using the Likert scale, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators ask families to rate overall their satisfaction with their child's pain control in the first five days after surgery.

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.