Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Median and Range of Numeric Pain Rating Scale (NPRS) score
研究概览
简要总结
Objectives: To compare the safety and efficacy of IV aminophylline versus IV neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).
Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.
Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group A, received IV aminophylline, and group NA, received IV neostigmine/atropine mixture.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NPRS score of ≥ 5
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 50 years
排除标准
- •Patients with NPRS score < 5
- •ASA physical status > II
- •Age < 21 years or > 50 years
- •Pregnant women
- •History of; chronic headache, Cluster headache, Migraine
- •History of; Convulsions, Cerebrovascular accident, Previous neurological diseases
- •Signs of meningismus
- •Bronchial asthma
- •Arrhythmia
- •Hypertension
- •Ischemic heart disease
- •Hyperthyroidism
研究组 & 干预措施
Group A (n=30)
Aminophylline group
干预措施: IV Aminophylline (Drug)
Group NA (n=30)
Neostigmine/Atropine group
干预措施: IV Neostigmine Methylsulfate + Atropine Sulphate (Drug)
结局指标
主要结局
Median and Range of Numeric Pain Rating Scale (NPRS) score
时间窗: 48 hours after initiation of treatment
NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, then every 12h till 48h)
次要结局
- Mean and Standard deviation of PDPH duration (hours) (mean±SD)(48 hours after initiation of treatment)
- Number of participants and Rate of Treatment-related complications(48 hours after initiation of treatment)