NCT07515456

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Theophylline
• Sumatriptan
• Gabapentin
• Post-Dural Puncture Headache

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Egypt