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

Le Bonheur Children's Hospital

Status and phase: Terminated; Phase 4

Conditions: Supracondylar Humerus Fracture

Treatments: Drug: Acetaminophen-Hydrocodone; Drug: Acetaminophen and Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT04905563

Post-op SCHF Pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Control

Other group

Description:

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:

Drug: Acetaminophen-Hydrocodone

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen and Ibuprofen