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Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache

NCT04257851 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-03

No results posted yet for this study

Summary

Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan in the treatment of post-dural puncture headache (PDPH).

Background: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.

Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group T, received oral theophylline, and group S, received oral sumatriptan.

Conditions

  • Post-Dural Puncture Headache

Interventions

DRUG

Theophylline Anhydrous Oral Tablet

Theophylline tablet (150 mg/12h)

DRUG

Sumatriptan Succinate Oral Tablet

Sumatriptan tablet (25 mg/12h)

Sponsors & Collaborators

  • Damanhour Teaching Hospital

    lead OTHER_GOV

Principal Investigators

  • Ahmed M Shaat, MD · Damanhour Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2021-05-15
Completion
2021-05-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257851 on ClinicalTrials.gov