Intravenous Fluids in Pediatric Migraine

Migraine Clinical Trial

Official title:

Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06182098
• Other study ID #: 23-029
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Dayton Children's Hospital
• Contact: Jonathan Elliott, MD
• Phone: (812) 582-3059
• Email: elliottj1[@]childrensdayton.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 21 Years

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine in Children

Intervention

Other:
• 1/2 maintenance fluids
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.

Drug:
• Ketorolac
0.5mg/kg, with a maximum of 30mg
• Diphenhydramine
0.5mg/kg, with a maximum of 25mg
• Prochlorperazine
0.15mg/kg, with a maximum of 10mg

Other:
• bolus
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour

Locations

Country	Name	City	State
United States	Dayton Children's Hosptial	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Dayton Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One hour change in pain	Mean change from baseline pain score, taken at one hour from beginning data collection. A 100 mm visual analog scale is used, with a higher score indicating higher pain. A greater change in pain score means more improved pain.	one hour
Secondary	Two hour change in pain	Mean change from baseline pain score, taken at two hours from beginning of data collection. A 100 mm visual analog scale is used, with a higher score indicating higher pain. A greater change in pain score means more improved pain.	two hours
Secondary	length of emergency stay	Mean duration of emergency department visit, reported in hours.	Through study completion, up to 24 hours after patient enrollment.
Secondary	return visits	percent of patients with additional visits to the emergency department within 48 hours of discharge	Through study completion, up to 48 hours after completion of study protocol.
Secondary	Admission rate	Percentage of patients admitted to the hospital for migraine	during emergency department visit, up to 24 hours after patient enrollment
Secondary	Resolution of pain	Percentage of patients with complete resolution of pain at the time of emergency discharge	Through study completion, up to 24 hours after enrollment
Secondary	50% reduction of pain	Percentage of patients with at least 50% reduction of pain from baseline, at the time of emergency discharge	Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department