Actively Recruiting
A Comparison of Theophylline Versus Sumatriptan and Gabapentin for Treating Post-Dural Puncture Headache: A Prospective Randomized Double-Blinded Study
Led by Tanta University · Updated on 2026-04-07
75
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of three drugs— theophylline, sumatriptan, and gabapentin— in treating post-dural puncture headache (PDPH), a common complication following spinal anesthesia or dural puncture. PDPH causes discomfort for patients and challenges for anesthetists. The study explores these medications because of their different mechanisms: theophylline may reduce blood flow and venous enlargement in the brain, sumatriptan may prevent cerebral blood vessel dilation related to cerebrospinal fluid leaks, and gabapentin is used for nerve-related pain conditions. Participants will be randomly assigned to one of three groups. One group will receive oral theophylline tablets of 150 mg every 12 hours. Another group will take oral sumatriptan tablets of 25 mg every 12 hours. The third group will receive 200 mg of gabapentin every 12 hours. Treatment is provided as tablets taken by mouth, and the study is designed to be double-blinded so neither participants nor researchers know which treatment is given. During the study, researchers will monitor headache severity 24 hours after treatment begins, along with headache duration, length of hospital stay (up to two weeks), any side effects related to treatment, use of additional pain relief, and patient satisfaction. The overall participation involves regular assessments during hospital stay, focusing on the immediate outcomes following drug administration. The trial starts in December 2024 and continues until November 2026, involving adults aged 21 to 50 years.
CONDITIONS
Brief Title
Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 21 to 50 years
- Both sexes
- American Society of Anesthesiologists (ASA) physical status 2
- Clinical diagnosis suggesting post-dural puncture headache (PDPH) based on International Headache Society criteria
- Numeric rating scale (NRS) of 5 or higher for headache severity
You will not qualify if you...
- Pregnant women
- History of chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, or 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 or any contraindication to oral intake
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours after drug treatment
Participants receive one of three study drugs: oral theophylline, sumatriptan, or gabapentin every 12 hours to treat post-dural puncture headache.
Multiple visits within 24 hours
Duration - Up to 2 weeks or until hospital discharge
Participants are monitored for length of hospital stay, treatment-related side effects, rescue analgesia consumption, and patient satisfaction up to discharge.
Assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
A
Asmaa R Eid, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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