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NCT Number: NCT07515456

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

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location status: Recruiting

Location contact

Asmaa R Eid, MSc

CONTACT

[email protected]

00201026382543

Jihan M Darwish, MD

SUB_INVESTIGATOR

Najat S Al Shamaa, MD

SUB_INVESTIGATOR

Omnia A El Miseery, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Theophylline

Drug

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.

Sumatriptan

Drug

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.

Gabapentin

Drug

Patients included in this group will receive 200 mg of gabapentin every 12 hours.

Primary outcomes

  1. Severity of headache

    Time frame: 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.

Secondary outcomes

  1. Post-Dural Puncture Headache duration

    Time frame: 24 hours after drug treatment.

    Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3.

  2. Length of hospital stay

    Time frame: Till the discharge from the hospital (Up to 2 weeks)

    Length of hospital stay will be recorded from the hospital admission till discharge.

  3. Treatment-related side effects

    Time frame: 24 hours after drug treatment.

    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.

  4. Total amount of rescue analgesia consumption

    Time frame: 24 hours after drug treatment.

    Total amount of rescue analgesia consumption will be measured.

  5. Degree of patient satisfaction

    Time frame: 24 hours after drug treatment.

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa R Eid, MSc

CONTACT

[email protected]

00201026382543

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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