Migraine, Migraine in Children
Conditions
Keywords
migraine, headache, pediatric, fluids, bolus
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.
Interventions
OTHER1/2 maintenance fluids
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
DRUGKetorolac
0.5mg/kg, with a maximum of 30mg
DRUGDiphenhydramine
0.5mg/kg, with a maximum of 25mg
DRUGProchlorperazine
0.15mg/kg, with a maximum of 10mg
OTHERbolus
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
Sponsors
Dayton Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One hour change in pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Two hour change in pain | 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. |
| length of emergency stay | Through study completion, up to 24 hours after patient enrollment. | Mean duration of emergency department visit, reported in hours. |
| Admission rate | during emergency department visit, up to 24 hours after patient enrollment | Percentage of patients admitted to the hospital for migraine |
| Resolution of pain | Through study completion, up to 24 hours after enrollment | Percentage of patients with complete resolution of pain at the time of emergency discharge |
| 50% reduction of pain | 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 |
| return visits | 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 |
Countries
United States
Contacts
Primary ContactJonathan Elliott, MD
Outcome results
None listed