Status:
ENROLLING_BY_INVITATION
SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Supracondylar Humerus Fracture
Eligibility:
All Genders
5-9 years
Phase:
PHASE4
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...
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 drug...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06187584
Start Date
April 15 2019
End Date
December 31 2026
Last Update
January 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Mercy Hospital & Clinics
Kansas City, Missouri, United States, 64108