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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2024-01-05

Brief Summary

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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.

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Detailed Description

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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

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Supracondylar Humerus Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control

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

Group Type OTHER

Acetaminophen-Hydrocodone

Intervention Type DRUG

Narcotic

Treatment

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.

Group Type EXPERIMENTAL

Acetaminophen and Ibuprofen

Intervention Type DRUG

Non-narcotic

Interventions

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Acetaminophen-Hydrocodone

Narcotic

Intervention Type DRUG

Acetaminophen and Ibuprofen

Non-narcotic

Intervention Type DRUG

Other Intervention Names

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Lortab Tylenol and Advil

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No