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Intravenous Fluids in Pediatric Migraine

Recruiting
5 - 21 years of age
Both
Phase N/A

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Overview

The goal of this clinical trial is to compare intravenous (IV) fluids in pediatric patients with migraine. The main questions it aims to answer are:

  • Does a large amount of fluids (bolus) improve pain
  • Does a large amount of fluids (bolus) reduce admissions to the hospital for migraine Participants will be asked to report their pain and have vital signs checked every 30 minutes for two hours.

Researchers will compare a large amount of fluids (bolus) to a small amount (half maintenance) to see if there is a difference in pain improvement.

Description

Patients will be randomized to one of two treatment groups. The intervention group will receive a 20 mL/kg bolus of normal saline (with a maximum of 1L), given over one hour.

The control group will receive normal saline at half maintenance (with a maximum of 50mL/hr) over one hour.

Both groups will receive:

  • ketoralac (Toradol), 0.5mg/kg, with a maximum of 30mg
  • diphenhydramine(Benadryl), 0.5mg/kg, with a maximum of 25mg
  • prochlorperazine(Compazine), 0.15mg/kg, with a maximum of 10mg

Pain score, heart rate, and blood pressure will be monitored every 30 minutes from the start of the medications/fluids being started, for a period of two hours. Pain will be recorded using a 100mm visual analog scale.

Eligibility

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

Study details

Migraine, Migraine in Children

NCT06182098

Dayton Children's Hospital

25 January 2024

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