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

  • STATUS
    Recruiting
  • End date
    May 21, 2026
  • participants needed
    150
  • sponsor
    Le Bonheur Children's Hospital
Updated on 21 September 2021

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.

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.

Details
Condition Supracondylar Humerus Fracture
Treatment Acetaminophen-Hydrocodone, Acetaminophen-Hydrocodone, Acetaminophen and Ibuprofen
Clinical Study IdentifierNCT04905563
SponsorLe Bonheur Children's Hospital
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

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
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