Intravenous Fluids for Childhood Migraine

N/A

Recruiting

Led By Jonathan Elliott, MD

Research Sponsored by Dayton Children's Hospital

Eligibility Criteria Checklist

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

Must have

Minimum pain score of 10mm

Be younger than 65 years old

Must not have

Initial pain score less than 10mm

Clinical suspicion of meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 24 hours after enrollment

Summary

This trial is comparing different amounts of fluids given through an IV to children with migraines. The trial wants to find out if giving a large amount of fluids quickly can help reduce pain and prevent hospital admissions

Who is the study for?

This trial is for children with migraines that have had at least one previous headache, a pain score of 10mm or more, and headaches lasting between 2 to 72 hours. They must also experience certain migraine characteristics like location and intensity of pain or associated symptoms like nausea. Children can't join if they have conditions such as shunted hydrocephalus, signs of meningitis, recent head trauma, are pregnant/breastfeeding, allergic to study meds or previously in the study.

What is being tested?

The trial tests whether giving a large amount (bolus) versus a small amount (half maintenance) of IV fluids helps reduce migraine pain and hospital admissions in kids. Pain levels will be monitored every half hour for two hours after treatment with additional medications like Ketorolac, Prochlorperazine, Diphenhydramine.

What are the potential side effects?

Possible side effects from the treatments may include reactions at the injection site due to IV fluids; stomach issues from Ketorolac; drowsiness or restlessness from Diphenhydramine; and dizziness or sleepiness from Prochlorperazine.

Eligibility Criteria

Inclusion Criteria

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

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My pain level is at least a 10mm on the pain scale.

Exclusion Criteria

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

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My initial pain level is low.

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I might have meningitis based on my symptoms.

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I might have a tumor in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 24 hours after enrollment. assessed at the time of discharge from the emergency department

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 24 hours after enrollment. assessed at the time of discharge from the emergency department

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 24 hours after enrollment. assessed at the time of discharge from the emergency department for reporting.