Intravenous Fluids in Pediatric Migraine

NCT06182098 | Unknown

• 1 other identifier: 23-029
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Migraine in Children

Keywords

migraine; headache; pediatric; fluids; bolus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Two hour change in pain

  two hours

• length of emergency stay

  Through study completion, up to 24 hours after patient enrollment.

• return visits

  Through study completion, up to 48 hours after completion of study protocol.

• Admission rate

  during emergency department visit, up to 24 hours after patient enrollment

• Resolution of pain

  Through study completion, up to 24 hours after enrollment

Study Arms (2)

Bolus

EXPERIMENTAL

Will receive a normal saline bolus

Drug: Ketorolac; Drug: Diphenhydramine; Drug: Prochlorperazine; Other: bolus

Control

PLACEBO COMPARATOR

Will receive 1/2 maintenance normal saline

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

Interventions

1/2 maintenance fluids OTHER

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

Also known as: Normal saline

Control

Ketorolac DRUG

0.5mg/kg, with a maximum of 30mg

Also known as: Toradol

Bolus; Control

Diphenhydramine DRUG

0.5mg/kg, with a maximum of 25mg

Also known as: Benadryl

Bolus; Control

Prochlorperazine DRUG

0.15mg/kg, with a maximum of 10mg

Also known as: Compazine

Bolus; Control

bolus OTHER

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

Also known as: normal saline

Bolus

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dayton Children's Hospital: lead

Study Sites (1)

Dayton Children's Hosptial

Dayton, Ohio, 45404, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Saline Solution; Ketorolac; Ketorolac Tromethamine; Diphenhydramine; Prochlorperazine; NOP-bolus regimen

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethylamines; Amines; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Jonathan Elliott, MD

  Dayton Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Elliott, MD

CONTACT

(812) 582-3059; elliottj1@childrensdayton.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: December 26, 2023
• Study Start: June 27, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

US (1)