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Randomized controlled trial of treatment expectation and intravenous fluid in pediatric migraine
Lawrence Richer1, William Craig, Brian Rowe
1Department of Pediatrics, University of Alberta, Edmonton, AB, Canada; Women and Children's Health Research Institute, Edmonton, AB, Canada.
Insights
Intravenous (IV) fluid hydration provided minimal pain relief for pediatric migraine patients in the emergency department (ED). Treatment expectation did not significantly impact headache reduction, and many patients experienced headache recurrence after discharge.
Area of Science:
- Pediatric Emergency Medicine
- Neurology
- Clinical Trials
Background:
- Intravenous (IV) fluid administration is a common but evidence-lacking treatment for pediatric migraine in emergency departments (EDs).
- This study investigated the efficacy of IV fluid hydration and the role of treatment expectation in managing pediatric migraine pain.
Purpose of the Study:
- To evaluate the pain response to intravenous fluid hydration in children and adolescents presenting to the ED with migraine.
- To determine if the expectation of receiving medication alongside IV fluids affects pain relief.
Main Methods:
- A single-blind, randomized trial involving 47 children and adolescents (aged 5-17) with migraine receiving 10 mL/kg IV 0.9% sodium chloride.
- Participants were allocated to either no expectation of medication (Group A) or expectation of simultaneous medication (Group B).
- Pain was assessed using the visual analog scale (VAS) at 30 minutes, with standard care provided thereafter.
Main Results:
- No statistically significant difference in VAS pain reduction was observed between the groups (mean change -12.3 mm vs. -12.7 mm, P=.936).
- A clinically meaningful reduction (≥30 mm on VAS) was achieved by 17.8% of participants, with no significant difference between groups.
- Headache recurrence was common, with 33.3% reporting moderate to severe headache at 24 hours.
Conclusions:
- Intravenous fluid hydration alone provides a small, clinically insignificant reduction in migraine pain for pediatric patients in the ED.
- Treatment expectation did not significantly enhance headache relief when IV fluids were administered.
- Migraine recurrence after ED treatment is frequent, highlighting the need for improved management strategies.
Objective:
(1) The primary objectives were (1) to assess the response to intravenous (IV) fluid in children presenting to the ED with migraine and; (2) to assess the effect of treatment expectation on the response to I.
Background:
Despite a lack of evidence for the practice, many emergency department (ED) migraine treatment protocols include a bolus of IV fluid. This study assessed the overall response to IV fluid hydration and the effect of expected medication treatment on the pain response among children and adolescents with migraine in an urban ED.
Methods:
A single-blind, randomized parallel arm trial of 10 mL/kg IV 0.9% sodium chloride for children and adolescents aged 5-17 years presenting to a pediatric ED with migraine. Patients were randomized into group A (no expectation of medication in combination with IV fluid) and group B (expectation that medication may be given simultaneously). All participants were treated with standard care following the 30-minute assessment.
Results:
Forty-seven participants were randomized and 2 were excluded; mean age was 13.3 years and 31 (67.4%) were females. Demographics and baseline characteristics were similar between groups. Overall, there was no statistically significant difference for the primary outcome - change from baseline on the visual analog scale (VAS) at 30 minutes with a mean change of -12.3 mm (standard deviation [SD] 17.9) in group A and -12.7 mm (SD 13.2) in group B (P = .936). The standardized difference between the 2 means (Cohen's d effect size) was low at 0.024 (95% confidence interval [CI] -0.56 to 0.61). Overall, complete headache relief was observed in only 1 participant; 16 of 45 (35.6%; 95% CI 21.8 to 51.2) had a reduction in headache of 33% or more and 8 of 45 (17.8%; 95% CI 6.1 to 29.4%) had a minimum clinical significant difference of 30 mm or more on VAS with 4 in each group. Thirteen of 39 patients with follow-up data (33.3%; 95% CI 19.1 to 50.2%) reported a moderate or severe headache at the 24-hour follow up with no difference between groups; only 3 patients returned to the ED. One participant reported a minor IV-related adverse event.
Conclusions:
The overall decrease in pain with IV fluid is small and clinically insignificant. Treatment expectation did not significantly influence headache relief at 30 minutes with IV fluid hydration in children or adolescents with migraine in the ED. The average relief of headache with IV fluid alone was small; however, a clinically meaningful response was observed in 17.8%. Recurrence of headache is common in 33% after ED discharge.
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