Intravenous Fluids for Childhood Migraine

Overseen By Jonathan Elliott, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Dayton Children's Hospital

Disqualifiers: Shunted hydrocephalus, Meningitis, Intracranial lesion, others

Compensation: Varies

Number of Visits: 30

Duration: 2 hours

134 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if administering a large amount of fluids through an IV can ease migraine pain and reduce hospital visits for children. Researchers will compare a large dose of fluids (bolus) with a smaller dose (1/2 maintenance fluids) to identify which is more effective in alleviating pain. Children who have experienced at least one headache, with pain lasting 2-72 hours and worsening with physical activity or causing symptoms like nausea, may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding new treatment approaches for migraines in children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these intravenous fluid treatments are safe for children with migraines?

Research shows that using IV fluids in children is generally safe. Hospitals often use IV fluids to keep children hydrated. In this trial, researchers compare two different amounts: a large amount given quickly (a bolus) and a smaller amount given steadily over time.

Although the study is in the early stages, the common use of IV fluids in medical care suggests they are usually well-tolerated. The main goal is to determine if a larger amount helps more with migraine pain and reduces the need for hospital stays. Researchers will check participants every 30 minutes for two hours to ensure safety and monitor for any side effects.

This setup demonstrates that researchers take precautions to ensure the treatment is as safe as possible for the children involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using intravenous fluids, specifically normal saline, to manage childhood migraines. Unlike standard migraine treatments, which often involve medications like pain relievers or anti-nausea drugs, this approach focuses on hydration through IV fluids. This method might offer a quicker and more direct way to alleviate migraine symptoms by addressing dehydration, which can be a migraine trigger. By comparing a normal saline bolus to a half-maintenance dose, the trial aims to determine the most effective hydration strategy, potentially offering a simple yet innovative treatment option for young migraine sufferers.

What evidence suggests that this trial's treatments could be effective for childhood migraine?

Research has shown that administering a quick, large amount of normal saline (a type of fluid), which participants in this trial may receive as part of the Bolus arm, can help treat migraines in children. One study found that children who received this treatment experienced significantly less headache pain. Another study reported success, with many children experiencing a 50% or greater reduction in pain. Although specific information on the exact fluid amount needed for migraines is limited, these findings suggest that a saline bolus might help reduce pain and possibly decrease hospital visits. ^{5 6 7 8 9}

Who Is on the Research Team?

Jonathan Elliott, MD

Principal Investigator

Dayton Children's

Are You a Good Fit for This Trial?

This trial is for children with migraines that have had at least one previous headache, a pain score of 10mm or more, and headaches lasting between 2 to 72 hours. They must also experience certain migraine characteristics like location and intensity of pain or associated symptoms like nausea. Children can't join if they have conditions such as shunted hydrocephalus, signs of meningitis, recent head trauma, are pregnant/breastfeeding, allergic to study meds or previously in the study.

Inclusion Criteria

I experience severe headaches that are pulsating and worsen with activity.

I have experienced at least one headache before.

My pain level is at least a 10mm on the pain scale.

Exclusion Criteria

Shunted hydrocephalus

I am showing signs of severe dehydration or shock.

My initial pain level is low.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a large bolus of IV fluids or half maintenance IV fluids, along with medications for migraine treatment

2 hours

Continuous monitoring every 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain reduction and emergency department discharge

24 hours

Return Visit Monitoring

Monitoring for any return visits to the emergency department within 48 hours of discharge

48 hours

What Are the Treatments Tested in This Trial?

Interventions

• 1/2 maintenance fluids
• bolus
• Diphenhydramine
• Ketorolac
• Prochlorperazine

Trial Overview

The trial tests whether giving a large amount (bolus) versus a small amount (half maintenance) of IV fluids helps reduce migraine pain and hospital admissions in kids. Pain levels will be monitored every half hour for two hours after treatment with additional medications like Ketorolac, Prochlorperazine, Diphenhydramine.

How Is the Trial Designed?

Group I: Bolus Experimental Treatment 4 Interventions

Will receive a normal saline bolus

Group II: Control Placebo Group 4 Interventions

Will receive 1/2 maintenance normal saline

Who Is Running the Clinical Trial?

Dayton Children's Hospital

Lead Sponsor

Trials

13

Recruited

5,029,000+

Published Research Related to This Trial

In a study of 83 pediatric patients with status migrainosus, continuous intravenous valproate was found to be an effective abortive therapy, with 66.2% of patients achieving excellent pain relief within 24 hours.

The treatment was safe, with minimal side effects (nausea 8.4%, vomiting 2.4%), and serum levels were maintained within the therapeutic range 91.9% of the time, indicating consistent dosing and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Intravenous Valproate as Abortive Therapy for Pediatric Status Migrainosus. Zafar, MS., Stewart, AM., Toupin, DN., et al.[2018]

A study involving 31 children with severe migraines showed that rapid intravenous infusions of valproic acid (VPA) resulted in an average pain reduction of 39.8% within about 63 minutes, indicating its efficacy as a treatment option.

The treatment was generally well tolerated, with only a few mild adverse events reported, suggesting that VPA could be a safe option for managing acute migraines in children, although further controlled trials are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of intravenous valproic acid in acute adolescent migraine. Reiter, PD., Nickisch, J., Merritt, G.[2013]

A survey of 154 pediatric critical care physicians across Europe and the Middle East revealed significant variability in prescribing practices for intravenous maintenance fluid therapy (IV-MFT) in acutely and critically ill children, highlighting a lack of standardized guidelines.

While most respondents used predefined formulas for IV-MFT and preferred balanced solutions in cases of altered serum levels, nearly 70% acknowledged a gap between current practices and ideal IV-MFT, indicating an urgent need for evidence-based guidelines and better training for healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous maintenance fluid therapy practice in the pediatric acute and critical care settings: a European and Middle Eastern survey. Morice, C., Alsohime, F., Mayberry, H., et al.[2022]

A survey of 147 pediatric residents across Canada revealed that over 75% chose isotonic intravenous fluids for maintenance therapy in infants and children, indicating a shift in practice to avoid the risks of hyponatremia associated with hypotonic fluids.

However, there was significant variability in fluid choices for neonates, influenced by the experience level of the residents and their geographical location, highlighting the need for clearer guidelines for this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Choice of maintenance intravenous fluids among paediatric residents in Canada. Kinlin, LM., Helmers, AJ., Friedman, JN., et al.[2022]

Isotonic intravenous fluids significantly reduce the risk of hyponatraemia in hospitalized children compared to hypotonic fluids, with a risk ratio of 0.48 based on data from 10 studies involving 1106 patients.

The evidence regarding the risk of hypernatraemia with isotonic fluids is inconclusive, but the overall incidence of hypernatraemia was low, suggesting isotonic fluids are a safer option for maintenance hydration in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. McNab, S., Ware, RS., Neville, KA., et al.[2018]

Intravenous valproate is effective in reducing headache pain during acute migraine attacks, with a significant reduction observed in 20 out of 24 patients who were not on prophylactic treatment and all 12 patients who were.

The study found no serious side effects from the treatment, confirming the safety of intravenous valproate, and suggested that patients on prophylactic valproate may experience even better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous sodium valproate in the treatment of acute migraine. Waberzinek, G., Marková, J., Mastík, J.[2013]

Pediatric migraine is a common and disabling condition, and while outpatient treatments often fail, intravenous management in emergency settings may be necessary, though current evidence is mostly retrospective and lacks robust randomized controlled trials.

The review analyzed 19 studies on various intravenous treatments for pediatric migraines, highlighting the need for well-designed prospective trials to improve treatment strategies, as most existing studies had limited quality and could not provide definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Migraine Treatment in Children and Adolescents. Werner, K., Qaiser, S., Kabbouche, M., et al.[2021]

In a study of 570 patients with acute migraines treated with intravenous metoclopramide, those who received intravenous fluid (IVF) showed less improvement in pain scores compared to those who did not receive IVF, indicating that IVF may not be beneficial for pain relief.

The administration of IVF did not lead to a higher rate of sustained headache freedom, suggesting that IVF does not enhance the effectiveness of migraine treatment in the emergency department setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous fluids for migraine: a post hoc analysis of clinical trial data. Balbin, JE., Nerenberg, R., Baratloo, A., et al.[2022]

In a study of 45 children and adolescents with migraines treated with IV fluids in the emergency department, the overall reduction in headache pain was small and clinically insignificant, with only 17.8% experiencing a meaningful improvement.

Expectations about receiving additional medication did not significantly affect the pain relief experienced from IV fluid treatment, indicating that IV hydration alone may not be an effective standalone treatment for migraines in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. Richer, L., Craig, W., Rowe, B.[2014]

In a study of 166 subjects with hereditary hemorrhagic telangiectasia (HHT) and migraines, those with pulmonary arteriovenous malformations (AVMs) were significantly more likely to experience migraine exacerbations after receiving intravenous contrast media during imaging procedures.

The research found that contrast-enhanced CT scans and contrast echocardiograms were particularly associated with migraine onset or worsening, suggesting that particulate emboli from these procedures may trigger migraines in susceptible individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injections of Intravenous Contrast for Computerized Tomography Scans Precipitate Migraines in Hereditary Hemorrhagic Telangiectasia Subjects at Risk of Paradoxical Emboli: Implications for Right-to-Left Shunt Risks. Patel, T., Elphick, A., Jackson, JE., et al.[2018]

In a study of 26 children and adolescents with status migraine, intravenous (IV) lidocaine was found to be a safe and effective treatment, with 90.3% of patients experiencing pain resolution.

On average, patients saw a significant reduction in pain scores within 16.3 hours, and the treatment was well-tolerated, with only one patient experiencing side effects that required interruption of the infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine. Ayulo, MA., Phillips, KE., Tripathi, S.[2019]

Current practice in Danish pediatric hospitals uses hypotonic maintenance fluids, which can cause dangerous low sodium levels (hypo-natremia) leading to serious neurological damage or even death in children.

The authors recommend switching to isotonic solutions with higher sodium content (140-154 mmol/l) and glucose to ensure safer hydration for fasting or low intake children, to prevent these severe health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intravenous fluid therapy in children]. Undlien, A., Rytter, M., Overgaard-Steensen, C., et al.[2020]

Recent research has raised concerns about the safety of hypotonic fluids in pediatric maintenance, linking them to iatrogenic hyponatremia, which can lead to serious health issues.

The American Academy of Pediatrics now recommends the routine use of isotonic fluids for pediatric maintenance, supporting their safety and efficacy as a better alternative in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance fluid management in pediatrics: Current practice and quality improvement achievements. Sensing, W., Wenker, M., Whitney, E.[2021]

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