Intravenous Fluids in Pediatric Migraine

December 13, 2023 updated by: Jonathan Elliott, MD, Dayton Children's Hospital

Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bolus
Will receive a normal saline bolus
Drug: Ketorolac
0.5mg/kg, with a maximum of 30mg
Other Names:
  • Toradol
Drug: Diphenhydramine
0.5mg/kg, with a maximum of 25mg
Other Names:
  • Benadryl
Drug: Prochlorperazine
0.15mg/kg, with a maximum of 10mg
Other Names:
  • Compazine
Other: bolus
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
Other Names:
  • normal saline
Placebo Comparator: Control
Will receive 1/2 maintenance normal saline
Drug: Ketorolac
0.5mg/kg, with a maximum of 30mg
Other Names:
  • Toradol
Drug: Diphenhydramine
0.5mg/kg, with a maximum of 25mg
Other Names:
  • Benadryl
Drug: Prochlorperazine
0.15mg/kg, with a maximum of 10mg
Other Names:
  • Compazine
Other: 1/2 maintenance fluids
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One hour change in pain
Time Frame: one hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Two hour change in pain
Time Frame: two hours
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
length of emergency stay
Time Frame: Through study completion, up to 24 hours after patient enrollment.
Mean duration of emergency department visit, reported in hours.
Through study completion, up to 24 hours after patient enrollment.
return visits
Time Frame: Through study completion, up to 48 hours after completion of study protocol.
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.
Admission rate
Time Frame: during emergency department visit, up to 24 hours after patient enrollment
Percentage of patients admitted to the hospital for migraine
during emergency department visit, up to 24 hours after patient enrollment
Resolution of pain
Time Frame: Through study completion, up to 24 hours after enrollment
Percentage of patients with complete resolution of pain at the time of emergency discharge
Through study completion, up to 24 hours after enrollment
50% reduction of pain
Time Frame: Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dayton Children's Hospital

Investigators

  • Principal Investigator: Jonathan Elliott, MD, Dayton Children's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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