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

Trial Summary

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 data supports the effectiveness of the treatment involving intravenous fluids for childhood migraine?

Research supports the use of isotonic intravenous fluids in children to prevent complications like hyponatremia (low sodium levels), which can lead to serious health issues. This suggests that isotonic fluids may be a safer option for maintaining hydration in children, potentially benefiting those with migraines. ^{1 2 3 4 5}

Is intravenous treatment for childhood migraine generally safe?

Research on intravenous treatments for migraines in children, including medications like valproate, shows they can be safe, with no serious side effects reported in studies. However, more well-designed studies are needed to confirm these findings. ^{6 7 8 9 10}

How does the treatment of 1/2 maintenance fluids differ from other treatments for childhood migraine?

The use of 1/2 maintenance fluids for childhood migraine is unique because it involves administering intravenous fluids (IVF) to hydrate the patient, which is a non-drug approach compared to other treatments that often involve medications like valproate or prochlorperazine. This method focuses on hydration, which may help alleviate migraine symptoms, especially when outpatient management is ineffective. ^{6 10 11 12 13}

What is the purpose of this trial?

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.

Research Team

Jonathan Elliott, MD

Principal Investigator

Dayton Children's

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Intravenous fluid therapy in children]. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Maintenance fluid management in pediatrics: Current practice and quality improvement achievements. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Intravenous maintenance fluid therapy practice in the pediatric acute and critical care settings: a European and Middle Eastern survey. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Choice of maintenance intravenous fluids among paediatric residents in Canada. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous Migraine Treatment in Children and Adolescents. [2021]

7. United States 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. [2018]

8. Sweden pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous sodium valproate in the treatment of acute migraine. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of IV Lidocaine in the Treatment of Children and Adolescents With Status Migraine. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of intravenous valproic acid in acute adolescent migraine. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous Intravenous Valproate as Abortive Therapy for Pediatric Status Migrainosus. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Intravenous fluids for migraine: a post hoc analysis of clinical trial data. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine. [2014]