Intravenous Fluids in Pediatric Migraine

Dayton Children's Hospital

Status: Enrolling

Conditions: Migraine; Migraine in Children

Treatments: Drug: Ketorolac; Other: 1/2 maintenance fluids; Drug: Prochlorperazine; Drug: Diphenhydramine; Other: bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT06182098

23-029

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups, including a placebo group

Bolus

Experimental group

Description:

Will receive a normal saline bolus

Treatment:

Other: bolus

Drug: Diphenhydramine

Drug: Prochlorperazine

Drug: Ketorolac

Control

Placebo Comparator group

Description:

Will receive 1/2 maintenance normal saline

Treatment:

Drug: Diphenhydramine

Drug: Prochlorperazine

Drug: Ketorolac

Other: 1/2 maintenance fluids