The Effects of Acetaminophen and Ibuprofen With and Without Magnesium in the Treatment of Primary Migraine in Childhood
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain-relief
研究概览
简要总结
Aim: The purpose of this study was to evaluate both the effects of ibuprofen and/or acetaminophen for the acute treatment of primary migraine in children in or out prophylactic treatment with magnesium.
Methods: The study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36) and the children ranging from the ages of 5 to 18 years with at least four attack/month of primary migraine were enrolled. A Visual Analogical Scale was used to evaluate pain intensity at the moment of admission to the study (start of the study) and every month up to 18 months later (end of the study).
详细描述
Study design The present work is a single-blind, balanced recruitment, parallel-group, single center study in outpatient children enrolled at the Pediatric Unit-Pugliese Ciaccio Hospital in Catanzaro, Italy, between January 2010 and June 2010.
This study had been approved by the Researchers Ethics Committee of the "Pugliese-Ciaccio" Hospital (protocol number 720/2010; EUDRACT NUMBER 2012-005737-36), and was conducted following the Declaration of Helsinki and the Guidelines for Good Clinical Practice criteria.
Population Children with migraine without aura (MoA) of both sexes aged from 5 to 16 years, with at least four attacks /month, were eligible for the study. MoA was diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2) [22].
Exclusion criteria were the following: mental retardation (IQ <70), genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome), hypothyroidism, psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD), neuromuscular disorders, epilepsy, obesity (BMI>95 percentiles), liver or renal diseases, gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn; hypersensitivity to medication studies.
Informed written consent was obtained by parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
- •aged from 5 to 18 years
- •at least four attacks /month
排除标准
- •mental retardation (IQ <70)
- •genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)
- •hypothyroidism
- •psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),
- •neuromuscular disorders,
- •epilepsy,
- •obesity (BMI>95 percentiles),
- •liver or renal diseases,
- •gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
- •hypersensitivity to medication studies.
研究组 & 干预措施
Acetaminophen
Acetaminophen 15 mg/kg oral single dose (n=40)
干预措施: acetaminophen 15 mg/kg (Drug)
Ibuprofen
Ibuprofen 10 mg/kg oral single dose (n=40)
干预措施: Ibuprofen 10 mg/kg (Drug)
Acetaminophen + magnesium 400 mg
Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg
干预措施: Magnesium 400Mg (Drug)
Acetaminophen + magnesium 400 mg
Acetaminophen 15 mg/kg oral single dose (n=40) + magnesium 400 mg
干预措施: acetaminophen 15 mg/kg (Drug)
ibuprofen + magnesium 400 mg
ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg
干预措施: Magnesium 400Mg (Drug)
ibuprofen + magnesium 400 mg
ibuprofen 10 mg/kg oral single dose (n=40) + magnesium 400 mg
干预措施: Ibuprofen 10 mg/kg (Drug)
结局指标
主要结局
Pain-relief
时间窗: 3 and 18 months
The primary endpoint was when pain-relief took place and pain intensity differences from baseline (0 hour) to 3 hours after drug treatment. This measurement was defined as the AUC for the sum of the 2 measurements (pain relief and pain intensity difference) at each time point from 0 to 3 hours. Pain was measured using the vas analogue scale (range 0-10, where 0 = no pain (score 0) and 100 mm = worst pain (score 10)
次要结局
未报告次要终点
研究者
Luca Gallelli
MD, PhD
University of Catanzaro