Is Theophylline More Effective Than Sumatriptan 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 [(median (range)]
研究概览
简要总结
Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan 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 T, received oral theophylline, and group S, received oral sumatriptan.
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
- •History of peripheral vascular disease (ischemic colitis)
- •Signs of meningismus
- •Dysrhythmia
- •Hypertension
- •Ischemic heart disease
- •Hyperthyroidism
- •Liver or Renal impairment
- •Use of selective serotonin reuptake inhibitors (SSRIs)
- •Use of ergotamine derivatives in the past 24 hours
- •Use of monoamine oxidase inhibitors (MAOIs) in the last two weeks
- •Use of any kind of opiates
- •Allergy to the study medications
- •Any contraindication of oral intake
研究组 & 干预措施
Group T (n=30)
Theophylline group
干预措施: Theophylline Anhydrous Oral Tablet (Drug)
Group S (n=30)
Sumatriptan group
干预措施: Sumatriptan Succinate Oral Tablet (Drug)
结局指标
主要结局
Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]
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, 18h, 24h, then every 12h till 48h)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
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, 18h, 24h, 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)
- Mean and Standard deviation of Length of hospital stay (days) (mean±SD)(48 hours after initiation of treatment)
- Number of participants and Rate of Treatment-related side effects(48 hours after initiation of treatment)