At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 137 enrolled
Drug / intervention
Hydrocodone/acetaminophen +2 moredrug
Likely dose
Hydrocodone/acetaminophen 0.15mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study
In Brief
A Phase 4 clinical trial evaluating Hydrocodone/acetaminophen, Acetaminophen, and 1 other intervention for Supracondylar Humerus Fracture. Completed, enrolled 137 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSupracondylar Humerus Fracture
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
Primary CompletionDec 2023
First PostedJan 2024
TodayJul 2026
First PostedJan 2, 2024
Enrollment StartApr 15, 2019
Primary CompletionDec 20, 2023
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 2.5 years ago
Interventions
Hydrocodone/acetaminophendrug
Hydrocodone/acetaminophen 0.15mg/kg PO q6
Acetaminophendrug
15mg/kg PO q6 hours
Ibuprofendrug
10mg/kg PO q6 hours