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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06187584
Enrollment
137
Registered
2024-01-02
Start date
2019-04-15
Completion date
2023-12-20
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supracondylar Humerus Fracture

Brief summary

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.

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.

Interventions

Hydrocodone/acetaminophen 0.15mg/kg PO q6

DRUGAcetaminophen

15mg/kg PO q6 hours

DRUGIbuprofen

10mg/kg PO q6 hours

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective, two-arm, parallel-group, randomized study conducted at a single center

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Parent Satisfaction With (Subject) Child's Pain ControlTwo hours post intervention and everyday at the same time as the initial response for five consecutive days post interventionUsing 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.
Number of Days of Medication UsageFirst follow up visit, occurring approximately one week postoperatively.Participants' parent completed a survey asking the number of days of medication use
Side Effects From MedicationFirst 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.
Use of Medication(s) Other Than Those Indicated by Their Physician to Control PainFirst 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.
Number of Calls to a Healthcare Provider for Breakthrough Pain RescueFirst follow up visit, occurring approximately one week postoperatively.Participant completed a survey asking for numerical count of phone calls for pain rescue.
Number of Visits to a Healthcare Provider for Breakthrough Pain RescueFirst follow up visit, occurring approximately one week postoperatively.Participant completed survey asking for count of visits for pain rescue.
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5Postoperative days 1-5Survey for number of doses taken by participant each postoperative day 1-5
Participant's Overall Pain ControlFirst 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
Overall Parent SatisfactionFirst 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.

Countries

United States

Baseline characteristics

Characteristic
Age, Categorical
<=18 years
85 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous75.79 Months
STANDARD_DEVIATION 13.59
Race/Ethnicity, Customized
American Indian or Alaska Native
0 Participants
Race/Ethnicity, Customized
Asian
1 Participants
Race/Ethnicity, Customized
Black or African American
7 Participants
Race/Ethnicity, Customized
Hispanic or Latino
5 Participants
Race/Ethnicity, Customized
More than one race
0 Participants
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
0 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
8 Participants
Race/Ethnicity, Customized
White
62 Participants
Region of Enrollment
United States
44 Participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
24 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 410 / 44
other
Total, other adverse events
0 / 410 / 44
serious
Total, serious adverse events
0 / 410 / 44

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026