NCT04905563

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Le Bonheur Children's Hospital · Academic / Other
• Sex: All
• Age: 4 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Supracondylar Humerus Fracture

Interventions

Type	Name	Description
DRUG	Acetaminophen-Hydrocodone	Narcotic
DRUG	Acetaminophen and Ibuprofen	Non-narcotic

Timeline

• Start date: 2021-06-07
• Primary completion: 2024-01-05
• Completion: 2024-01-05
• First posted: 2021-05-27
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study