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Bolus for 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 24 hours after patient enrollment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

One hour change in pain

Secondary outcome measures

50% reduction of pain

Admission rate

Resolution of pain

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BolusExperimental Treatment4 Interventions

Will receive a normal saline bolus

Group II: ControlPlacebo Group4 Interventions

Will receive 1/2 maintenance normal saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diphenhydramine

2002

Completed Phase 4

~1170

Prochlorperazine

2015

Completed Phase 4

~550

Ketorolac

2014

Completed Phase 4

~1760

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dayton Children's HospitalLead Sponsor

12 Previous Clinical Trials

5,028,395 Total Patients Enrolled

Jonathan Elliott, MDPrincipal InvestigatorDayton Children's

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this clinical trial?

"To meet the requirements for participation in this trial, patients need to be within the age range of 5 to 21 and have a diagnosis of migraine. The study aims to recruit approximately 134 eligible participants."

Answered by AI

Are participants still being enrolled for this ongoing medical study?

"Based on the information provided by clinicaltrials.gov, this investigation is currently in the recruitment phase. It was initially posted on June 27th, 2023 and underwent its most recent update on December 13th, 2023."

Answered by AI

What is the current number of individuals being enrolled in this clinical trial?

"Indeed, according to the details provided on clinicaltrials.gov, this study is actively seeking eligible participants. The initial posting of the trial took place on June 27th, 2023 and it was last updated on December 13th, 2023. A total of 134 individuals are being enrolled in this clinical trial which will take place at a single site."

Answered by AI

Is there an age criterion for the inclusion of participants in this study, specifically targeting individuals aged 55 and above?

"Applicants who meet the requirements for this study must fall within the age range of 5 to 21. Among all clinical trials, there are a total of 40 trials specifically targeting individuals under the age of 18 and an additional 121 trials focused on those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intravenous Fluids in Pediatric Migraine

Jonathan Elliott, MD 2023. "Intravenous Fluids in Pediatric Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06182098.

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