Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Theophylline, Sumatriptan, Gabapentin.
- Who it may be relevant to
- Registry conditions: Theophylline, Sumatriptan, Gabapentin, Post-Dural Puncture Headache. Basic parameters: 21 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug 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. - Drug 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. - Drug Gabapentin
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
Primary outcome measures
- Severity of headache [Time frame: 24 hours after drug treatment.]
Secondary outcome measures (5)
- Post-Dural Puncture Headache duration [Time frame: 24 hours after drug treatment.]
- Length of hospital stay [Time frame: Till the discharge from the hospital (Up to 2 weeks)]
- Treatment-related side effects [Time frame: 24 hours after drug treatment.]
- Total amount of rescue analgesia consumption [Time frame: 24 hours after drug treatment.]
- Degree of patient satisfaction [Time frame: 24 hours after drug treatment.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT07515456 · 36265MD314/11/24