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

Study Overview
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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.

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.

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

Conditions
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Supracondylar Humerus Fracture

Intervention / Treatment
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* Drug: Acetaminophen-Hydrocodone
* Drug: Acetaminophen and Ibuprofen


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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 | Drug: Acetaminophen-Hydrocodone<br>* Narcotic<br>* Other names: Lortab;|
| Experimental: Treatment<br>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. | Drug: Acetaminophen and Ibuprofen<br>* Non-narcotic<br>* Other names: Tylenol and Advil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elbow surgery, Pain