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Nonsteroidal Anti-inflammatory Drug

NSAIDs vs Opioids for Post-op Pain in Broken Arms

Phase 4

Waitlist Available

Led By Lindsey Locke, MSN

Research Sponsored by Le Bonheur Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Isolated supracondylar humerus fracture undergoing closed reduction with percutaneous pinning (CRPP)

Be younger than 18 years old

Must not have

Liver or renal disease

Vascular compromise and/or compartment syndrome upon admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours (duration of post-operative stay)

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Drug Has Already Been Approved

Summary

This trial will compare the pain-relieving effects of acetaminophen + ibuprofen to those of acetaminophen-hydrocodone in children with broken elbows who need surgery.

Who is the study for?

This trial is for children needing surgery for a broken elbow (supracondylar humerus fracture) who haven't been taking NSAIDs or opioids regularly, don't have bleeding disorders, liver or kidney disease, juvenile arthritis, multiple injuries at the time of diagnosis, vascular issues upon admission, or allergies to acetaminophen, ibuprofen or hydrocodone.

What is being tested?

The study compares pain control in children post-elbow surgery using two methods: one group receives acetaminophen and ibuprofen together while the other gets a combination of acetaminophen-hydrocodone. The goal is to see if non-opioid drugs can effectively replace opioids.

What are the potential side effects?

Possible side effects from these medications include stomach upset and potential liver damage with excessive use of acetaminophen; ibuprofen may cause kidney problems and increase bleeding risk. Acetaminophen-hydrocodone can be addictive and may cause constipation and drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having a specific arm bone fracture fixed without open surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver or kidney disease.

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I was diagnosed with reduced blood flow or pressure build-up in my muscles upon hospital admission.

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I have a history of bleeding disorders.

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I have been diagnosed with juvenile arthritis.

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I have a bleeding disorder or had open fractures or other major injuries when diagnosed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours (duration of post-operative stay)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours (duration of post-operative stay)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours (duration of post-operative stay) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Scores

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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 II: ControlExperimental Treatment1 Intervention

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

0 / 6Eligibility criteria met