A Comparison Between Safety and Efficacy of Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache: A Prospective Randomized Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Severity of headache
研究概览
简要总结
The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache.
详细描述
Post-dural puncture headache (PDPH) is a frequent complication of spinal anaesthesia or dural puncture and is an uncomfortable situation for both the patient and the anesthetist.
Theophylline as a form of methyl xanthine, is an adenosine receptor antagonist and can decrease intracranial blood flow and venous enlargement. Evidence shows that intravenous theophylline infusion is a rapid, effective, non-invasive, practical, and low-cost method to treat post-spinal headache.
Sumatriptan is a selective agonist of 5-hydroxytrytamine-like receptors and is used in the treatment of migraine. It has been used in the treatment of PDPH where it may prevent cerebral vasodilation associated with the cerebrospinal fluid (CSF) leak.
Gabapentin is a structural analogue of gamma amino butyric acid; it was used as an anticonvulsant drug for the first time. This drug is now applied in diabetic neuropathy, neuropathic cancer pain and inflammatory injury.
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
- Double (Participant, Outcomes Assessor)
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
- •Age from 21 to 50 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status ≤ II.
- •Patient's selection for this study will be based on clinical diagnosis suggesting post-dural puncture headache (PDPH) based on the International Headache Society criteria.
- •Patients with numeric rating scale (NRS) of ≥ 5.
排除标准
- •Pregnant women.
- •History of; chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, and previous neurological diseases.
- •Signs of meningismus.
- •Dysrhythmia.
- •Hypertension.
- •Ischemic heart disease.
- •Hyperthyroidism.
- •Peripheral vascular disease (ischemic colitis).
- •Liver or renal impairment.
- •Use of selective serotonin reuptake inhibitors.
- •Use of ergotamine derivatives in the past 24 hours.
- •Use of monoamine oxidase inhibitors in the last 2 weeks.
- •Use of any kind of opiates.
- •Allergy to the study medications and any contraindication of oral intake.
研究组 & 干预措施
Group S
Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours.
干预措施: Sumatriptan (Drug)
Group T
Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours.
干预措施: Theophylline (Drug)
Group G
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
干预措施: Gabapentin (Drug)
结局指标
主要结局
Severity of headache
时间窗: 24 hours after drug treatment.
Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.
次要结局
- Post-Dural Puncture Headache duration(24 hours after drug treatment.)
- Length of hospital stay(Till the discharge from the hospital (Up to 2 weeks))
- Treatment-related side effects(24 hours after drug treatment.)
- Total amount of rescue analgesia consumption(24 hours after drug treatment.)
- Degree of patient satisfaction(24 hours after drug treatment.)
研究者
Asmaa Ragab Mohamed
Assistant Lecturer of Anesthesiology, Surgical ICU and Pain Management, Tanta University, Tanta, Egypt.
Tanta University