NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

Phase 4

Terminated

Interventions: Drug: Acetaminophen-Hydrocodone
Drug: Acetaminophen and Ibuprofen

Brief Summary: 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.

Detailed Description: For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Control	Acetaminophen-Hydrocodone	Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Treatment	Acetaminophen and Ibuprofen	Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.

Primary Outcome Measures

Name	Time	Method
Pain Scores	24 hours (duration of post-operative stay)	Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).

Secondary Outcome Measures

Name	Time	Method

Locations (1): Le Bonheur Children's Hospital
🇺🇸
Memphis, Tennessee, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States