Vaswani N D, Lamba Preet, Arya Vandana, Lekhwani Seema
Pediatrics, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, IND.
Pediatrics, Government Medical College & Hospital, Chandigarh, IND.
Cureus. 2024 Nov 27;16(11):e74563. doi: 10.7759/cureus.74563. eCollection 2024 Nov.
Background Pediatric migraine is a primary headache affecting daily activities and causing significant disability among children. However, clarity on the usage of prophylactic medications in children is yet to be established. This study was conducted with the aim of comparing the efficacy and safety of flunarizine and propranolol in the prophylaxis of pediatric migraine. Methodology An open-label randomized trial with parallel group assignment was conducted in the Department of Pediatrics of a tertiary care hospital in Northern India among patients aged five to 14 years with migraine having Pediatric Migraine Disability Assessment (PedMIDAS) score of 11 to 139 and a headache frequency of four or more days over a baseline period of 28 days. Enrolled patients were assigned randomly to receive either flunarizine (5 mg/day HS for the first month and then 10 mg/day HS for the next two months) or propranolol (1 mg/kg/day in two divided doses for three months) and then followed up monthly for three months for outcomes. The primary outcome was the proportion of children with a 50% or more reduction in the number of headache days compared to the 28-day baseline period with the last 28 days of the 12-week trial period. Secondary outcomes were headache-related disability (as measured by the absolute change in PedMIDAS score), the absolute change in the number of headache days, and the proportion and nature of adverse effects in the two groups. Results A total of 40 patients underwent randomization (20 in each group). Baseline parameters were comparable in the two groups. The primary outcome, that is, a 50% or more reduction in the number of headache days, was achieved in 10 out of 20 (50%) patients in the flunarizine group and 11 out of 20 (55%) patients in the propranolol group (p = 0.752). Both groups were comparable in terms of the primary outcome. There were also no significant between-group differences in terms of headache-related disability (change in PedMIDAS: 8.2 ± 2.97 in the flunarizine group vs 8.7 ± 3.95 in the propranolol group, p = 0.924) and absolute reduction in the number of headache days (4.3 ± 2.36 in the flunarizine group vs 4.3 ± 2.11 in the propranolol group, p = 0.989). Minor adverse effects like nausea, vomiting, drowsiness, and fatigue were comparable in the two groups. None of the patients reported any serious adverse events. Conclusion Flunarizine is as effective as propranolol for the prophylactic management of children with migraine. Both drugs were well-tolerated and safe.
儿童偏头痛是一种影响日常活动并导致儿童严重残疾的原发性头痛。然而，儿童预防性药物的使用尚不清楚。本研究旨在比较氟桂利嗪和普萘洛尔预防儿童偏头痛的疗效和安全性。
在印度北部一家三级护理医院的儿科进行了一项开放标签的平行组随机试验，研究对象为5至14岁偏头痛患儿，其儿童偏头痛残疾评估（PedMIDAS）评分为11至139，在28天的基线期内头痛频率为4天或更多天。入选患者被随机分配接受氟桂利嗪（第一个月每晚5mg，接下来两个月每晚10mg）或普萘洛尔（1mg/kg/天，分两次服用，共三个月），然后随访三个月以观察结果。主要结局是与12周试验期最后28天的28天基线期相比，头痛天数减少50%或更多的儿童比例。次要结局包括头痛相关残疾（通过PedMIDAS评分的绝对变化衡量）、头痛天数的绝对变化以及两组不良反应的比例和性质。
共有40例患者进行了随机分组（每组20例）。两组基线参数具有可比性。主要结局方面，即头痛天数减少50%或更多，氟桂利嗪组20例患者中有10例（50%）达到，普萘洛尔组20例患者中有11例（55%）达到（p = 0.752）。两组在主要结局方面具有可比性。在头痛相关残疾方面（氟桂利嗪组PedMIDAS变化：8.2±2.97，普萘洛尔组8.7±3.95，p = 0.924）和头痛天数的绝对减少方面（氟桂利嗪组4.3±2.36，普萘洛尔组4.3±2.11，p = 0.989），两组之间也没有显著差异。两组恶心、呕吐、嗜睡和疲劳等轻微不良反应相当。没有患者报告任何严重不良事件。
氟桂利嗪在预防儿童偏头痛方面与普萘洛尔同样有效。两种药物耐受性良好且安全。
