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NCT06182098 | RECRUITING | Migraine

Intravenous Fluids in Pediatric Migraine
Sponsor:

Dayton Children's Hospital

Information provided by (Responsible Party):

Jonathan Elliott, MD

Brief Summary:

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.

Condition or disease

Migraine

Migraine in Children

Intervention/treatment

1/2 maintenance fluids

Ketorolac

Diphenhydramine

Prochlorperazine

bolus

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 134 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
Actual Study Start Date : 2023-06-27
Estimated Primary Completion Date : 2025-06
Estimated Study Completion Date : 2025-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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
Intravenous Fluids in Pediatric Migraine

Location Details

NCT06182098

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How to Participate

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Locations

RECRUITING

United States, Ohio

Dayton Children's Hosptial

Dayton, Ohio, United States, 45404