Clinical trial NCT06182098: Intravenous Fluids in Pediatric Migraine
Official title: Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Migraine in Children
Keywords: migraine
headache
pediatric
fluids
bolus
Lead sponsor: Dayton Children's Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 134
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: One hour change in pain
timeFrame: one hour
Secondary outcomes:
measure: Two hour change in pain
timeFrame: two hours
measure: length of emergency stay
timeFrame: Through study completion, up to 24 hours after patient enrollment.
measure: return visits
timeFrame: Through study completion, up to 48 hours after completion of study protocol.
measure: Admission rate
timeFrame: during emergency department visit, up to 24 hours after patient enrollment
measure: Resolution of pain
timeFrame: Through study completion, up to 24 hours after enrollment
measure: 50% reduction of pain
timeFrame: Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Dayton Children's Hosptial
state: Ohio
Study officials:
affiliation: Dayton Children's
name: Jonathan Elliott, MD
role: PRINCIPAL_INVESTIGATOR
References: