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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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus | Experimental | Will receive a normal saline bolus |
|
| Control | Placebo Comparator | Will receive 1/2 maintenance normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1/2 maintenance fluids | Other | Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| length of emergency stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Elliott, MD | Contact | (812) 582-3059 | elliottj1@childrensdayton.org |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Elliott, MD | Dayton Children's | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dayton Children's Hosptial | Recruiting | Dayton | Ohio | 45404 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D004155 | Diphenhydramine |
| D011346 | Prochlorperazine |
| C073681 | NOP-bolus regimen |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ketorolac | Drug | 0.5mg/kg, with a maximum of 30mg |
|
|
| Diphenhydramine | Drug | 0.5mg/kg, with a maximum of 25mg |
|
|
| Prochlorperazine | Drug | 0.15mg/kg, with a maximum of 10mg |
|
|
| bolus | Other | 20mL/kg normal saline bolus, with a maximum of 1L, given over one hour |
|
|
Mean duration of emergency department visit, reported in hours. |
| Through study completion, up to 24 hours after patient enrollment. |
| 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. |
| Admission rate | Percentage of patients admitted to the hospital for migraine | during emergency department visit, up to 24 hours after patient enrollment |
| 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 |
| 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 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007213 |
| Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |