MigraineNCT06182098
Intravenous Fluids in Pediatric Migraine
A study testing 1/2 maintenance fluids, Ketorolac and Diphenhydramine in people with Migraine and Migraine in Children, run by Dayton Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Migraine in Children
- What is being tested?
- 1/2 maintenance fluids, Ketorolac and Diphenhydramine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Pregnancy or breastfeeding
- Initial pain score less than 10mm
- Allergy to study medications
- Patients previously participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dayton Children's Hosptial
Dayton, Ohio, 45404
Jonathan Elliott, MD, 812-582-3059, elliottj1@childrensdayton.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine, Migraine in Children
- Being tested
- 1/2 maintenance fluids, Ketorolac, Diphenhydramine, Prochlorperazine, bolus
- Keywords
- migraine, headache, pediatric, fluids, bolus
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1/2 maintenance fluidsOther
Also called Normal saline
Patients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour.
KetorolacDrug
Also called Toradol
0.5mg/kg, with a maximum of 30mg
DiphenhydramineDrug
Also called Benadryl
0.5mg/kg, with a maximum of 25mg
ProchlorperazineDrug
Also called Compazine
0.15mg/kg, with a maximum of 10mg
bolusOther
Also called normal saline
20mL/kg normal saline bolus, with a maximum of 1L, given over one hour
| Study group | Role | What they receive |
|---|---|---|
| Bolus | Experimental | Will receive a normal saline bolus Receives: Drug: Ketorolac; Drug: Diphenhydramine; Drug: Prochlorperazine; Other: bolus |
| Control | Placebo comparator | Will receive 1/2 maintenance normal saline Receives: Other: 1/2 maintenance fluids; Drug: Ketorolac; Drug: Diphenhydramine; Drug: Prochlorperazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour
Secondary outcomes (6)
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.
Measured: two hours
length of emergency stay
Mean duration of emergency department visit, reported in hours.
Measured: 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
Measured: Through study completion, up to 48 hours after completion of study protocol.
Admission rate
Percentage of patients admitted to the hospital for migraine
Measured: 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
Measured: 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
Measured: Through study completion, up to 24 hours after enrollment. Assessed at the time of discharge from the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start27 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dayton Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Elliott, MD, Dayton Children's Hospital
- Investigators
- Jonathan Elliott, MD, Principal investigator, Dayton Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182098
- Sponsor's protocol ID
- 23-029
- Status last verified
- Dec 2023
- First submitted
- 29 Aug 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Intravenous Fluids in the Emergent Treatment of Pediatric Migraine
- ClinicalTrials.gov ID
- NCT06182098
- Acronym / sponsor ID
- 23-029
- Conditions
- Migraine, Migraine in Children
- Keywords
- migraine, headache, pediatric, fluids, bolus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Dayton Children's HospitalUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bolus | Experimental | Drug: Ketorolac, Drug: Diphenhydramine, Drug: Prochlorperazine, Other: bolusWill receive a normal saline bolus |
| Control | Placebo comparator | Other: 1/2 maintenance fluids, Drug: Ketorolac, Drug: Diphenhydramine, Drug: ProchlorperazineWill receive 1/2 maintenance normal saline |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1/2 maintenance fluidsAlso: Normal salinePatients will receive 1/2 maintenance normal saline (with a maximum of 50 mL/hr), over one hour. | Other | Control |
| KetorolacAlso: Toradol0.5mg/kg, with a maximum of 30mg | Drug | Bolus, Control |
| DiphenhydramineAlso: Benadryl0.5mg/kg, with a maximum of 25mg | Drug | Bolus, Control |
| ProchlorperazineAlso: Compazine0.15mg/kg, with a maximum of 10mg | Drug | Bolus, Control |
| bolusAlso: normal saline20mL/kg normal saline bolus, with a maximum of 1L, given over one hour | Other | Bolus |
Primary outcome
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.
6 secondary outcomes
Two hour change in pain
Time frame: two hours
length of emergency stay
Time frame: 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.
Admission rate
Time frame: 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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Elliott, MD principal investigator
Dayton Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1/2 maintenance fluids, Ketorolac and Diphenhydramine in people with Migraine and Migraine in Children, run by Dayton Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Elliott, MD ((812) 582-3059, elliottj1@childrensdayton.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One hour change in pain (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023; AzTrials last refreshed its copy on 1 Nov 2026.