Phase 4
N=86
Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management
Supracondylar Humerus Fracture
Bottom Line
View on ClinicalTrials.gov: NCT06187584 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale. — 4.10; 4.46; 3.82; 3.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydrocodone/acetaminophen (Drug); Acetaminophen (Drug); Ibuprofen (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Children's Mercy Hospital Kansas City
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale. |
4.10; 4.46; 3.82; 3.4; 2.8; 2.85 | — |
| SECONDARY Parent Satisfaction With (Subject) Child's Pain Control |
3.71; 3.83; 4.13; 3.97; 4.38; 4.47 | — |
| SECONDARY Number of Days of Medication Usage |
2.48; 4.65 | — |
| SECONDARY Side Effects From Medication |
10; 4 | — |
| SECONDARY Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain |
0; 0; 5; 0 | — |
| SECONDARY Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue |
2; 1; 0; 0 | — |
| SECONDARY Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue |
0; 0 | — |
| SECONDARY Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5 |
1.38; 2.67; 1.25; 2.23; 0.53; 1.67 | — |
| SECONDARY Participant's Overall Pain Control |
4.56; 4.19 | — |
| SECONDARY Overall Parent Satisfaction |
4.67; 4.35 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06187584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.