Comparing IV fluids for treating migraines in children
Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
NA · Dayton Children's Hospital · NCT06182098
This study is testing if giving kids with migraines a big dose of IV fluids helps them feel better compared to a smaller amount of fluids.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | Dayton Children's Hospital (other) |
| Locations | 1 site (Dayton, Ohio) |
| Trial ID | NCT06182098 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intravenous (IV) fluids in alleviating migraine pain in pediatric patients. Participants will be randomly assigned to receive either a large bolus of normal saline or a smaller amount of fluids over a one-hour period. Pain levels will be monitored using a visual analog scale, along with vital signs checked every 30 minutes for two hours. The study seeks to determine if a larger volume of fluids can improve pain relief and reduce hospital admissions for migraine treatment.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients with a history of migraines who meet specific pain and symptom criteria.
Not a fit: Patients with conditions such as shunted hydrocephalus, significant dehydration, or those with a recent history of head trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from migraines.
How similar studies have performed: While the approach of using IV fluids for migraine treatment is not widely tested in children, similar studies in adults have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 1 prior headache * Minimum pain score of 10mm * Headache lasting 2-72 hours * At least two of the following four: 1 Bifrontal/bitemporal or unilateral location, 2 Pulsating quality, 3 Moderate or severe pain intensity, 4 Aggravation by or causing avoidance of routine physical activity * At least one of the following: 1 Nausea and/or vomiting, 2Photophobia and phonophobia, 3 Not better accounted for by another ICHD-3 diagnosis Exclusion Criteria: * Shunted hydrocephalus * Temperature equal to or greater than 38.5C * Clinical suspicion of meningitis * Known or suspected intracranial lesion * Clinical evidence of significant dehydration (or signs of shock, or attending discretion) * Head trauma in previous 7 days * Pregnancy or breastfeeding * Initial pain score less than 10mm * Allergy to study medications * Patients previously participating in the study
Where this trial is running
Dayton, Ohio
- Dayton Children's Hosptial — Dayton, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Jonathan Elliott, MD — Dayton Children's
- Study coordinator: Jonathan Elliott, MD
- Email: elliottj1@childrensdayton.org
- Phone: (812) 582-3059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine, Migraine in Children, migraine, headache, pediatric, fluids, bolus