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RecruitingNot ApplicableNCT07515456

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

Sponsor

Tanta University

Enrollment

75 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

TheophyllineSumatriptanGabapentin

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.

Eligibility

Min Age: 21 YearsMax Age: 50 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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.

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Interventions

DRUGTheophylline

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.

DRUGSumatriptan

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.

DRUGGabapentin

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

Locations(1)

Tanta University

Tanta, El-Gharbia, Egypt

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NCT07515456