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

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.

Study Overview

• Status: Recruiting
• Conditions: Post-Dural Puncture Headache; Gabapentin; Theophylline; Sumatriptan
• Intervention / Treatment: Drug: Theophylline; Drug: Sumatriptan; Drug: Gabapentin

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.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asmaa R Eid, MSc; Phone Number: 00201026382543; Email: asmaaragabeid@gmail.com

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Asmaa R Eid, MSc; Phone Number: 00201026382543; Email: asmaaragabeid@gmail.com
      • Sub-Investigator: Najat S Al Shamaa, MD
      • Sub-Investigator: Jihan M Darwish, MD
      • Sub-Investigator: Omnia A El Miseery, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
Experimental: Group G; Patients included in this group will receive 200 mg of gabapentin every 12 hours.	Drug: Gabapentin; Patients included in this group will receive 200 mg of gabapentin every 12 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of headache	Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.	24 hours after drug treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Dural Puncture Headache duration	Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3.	24 hours after drug treatment.
Length of hospital stay	Length of hospital stay will be recorded from the hospital admission till discharge.	Till the discharge from the hospital (Up to 2 weeks)
Treatment-related side effects	Treatment-related side effects such as palpitation, dizziness, gastric irritation, nausea/vomiting, diarrhea, warm sensations in the body, tingling sensation, and tightness in the chest, throat, neck, or jaws will be recorded.	24 hours after drug treatment.
Total amount of rescue analgesia consumption	Total amount of rescue analgesia consumption will be measured.	24 hours after drug treatment.
Degree of patient satisfaction	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)	24 hours after drug treatment.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Post-Dural Puncture Headache; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Acids, Acyclic; Carboxylic Acids; Alkaloids; Amides; Amines; Indoles; Purinones; Purines; Amino Acids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Carbocyclic; Sulfonamides; Sulfones; Tryptamines; Cyclohexanecarboxylic Acids; Xanthines; Gabapentin; Sumatriptan; Theophylline
• Other Study ID Numbers: 36265MD314/11/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No