Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study

Post-op SCHF Pain

The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.

2021-06-07

2024-01-05

2024-01-05

Terminated

Early phase I

30

Inclusion Criteria: * isolated supracondylar humerus fracture * undergoing closed reduction with percutaneous pinning (CRPP) Exclusion Criteria: * Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone * Liver or renal disease * history of bleeding disorder * medical diagnosis of juvenile arthritis * on chronic NSAIDs or Opioids PRIOR to the procedure * medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma) * vascular compromise and/or compartment syndrome upon admission

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-03-08