Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Theophylline
  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.
• Препарат Sumatriptan
  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.
• Препарат Gabapentin
  Patients included in this group will receive 200 mg of gabapentin every 12 hours.

Первичные конечные точки

• Severity of headache [Срок оценки: 24 hours after drug treatment.]

Вторичные конечные точки (5)

• Post-Dural Puncture Headache duration [Срок оценки: 24 hours after drug treatment.]
• Length of hospital stay [Срок оценки: Till the discharge from the hospital (Up to 2 weeks)]
• Treatment-related side effects [Срок оценки: 24 hours after drug treatment.]
• Total amount of rescue analgesia consumption [Срок оценки: 24 hours after drug treatment.]
• Degree of patient satisfaction [Срок оценки: 24 hours after drug treatment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Tanta University — Tanta

Идентификаторы

NCT: NCT07515456 · 36265MD314/11/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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