Treating post-dural puncture headache with theophylline, sumatriptan, or gabapentin
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
This trial will try theophylline, sumatriptan, and gabapentin to see which best relieves moderate-to-severe post-dural puncture headache in adults aged 21–50.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT07515456 on ClinicalTrials.gov |
What this trial studies
Adults aged 21–50 with clinically diagnosed post-dural puncture headache and a pain score of at least 5 are enrolled at Tanta University and given one of three medications (theophylline, sumatriptan, or gabapentin). The study compares how well each drug reduces headache severity and records side effects to compare safety. Treatments are given per protocol and patients are followed for clinical response and adverse events. Outcomes focus on pain relief magnitude and tolerability.
Who should consider this trial
Good fit: Adults 21–50 years old with PDPH meeting International Headache Society criteria, ASA physical status I–II, and a numeric pain rating of ≥5 are the intended participants.
Not a fit: People who are pregnant, have chronic headache disorders, significant cardiovascular disease, thyroid/liver/kidney impairment, or contraindications to the study drugs are unlikely to benefit from these treatments.
Why it matters
Potential benefit: If successful, the trial could identify an effective, low-cost medication option to relieve PDPH without needing invasive procedures.
How similar studies have performed: Smaller previous reports have suggested benefit from theophylline and sumatriptan for PDPH, but direct head-to-head comparative data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Asmaa R Eid, MSc
- Email: asmaaragabeid@gmail.com
- Phone: 00201026382543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.