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

Supracondylar Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04905563
• Other study ID #: Post-op SCHF Pain
• Status: Terminated
• Phase: Phase 4
• Start date: June 7, 2021
• Est. completion date: January 5, 2024

Study information

• Verified date: March 2024
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Drug:
• Acetaminophen-Hydrocodone
Narcotic
• Acetaminophen and Ibuprofen
Non-narcotic

Locations

Country	Name	City	State
United States	Le Bonheur Children's Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital	The Campbell Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).	24 hours (duration of post-operative stay)