An interventional study of Theophylline and Sumatriptan in Theophylline, Sumatriptan and Gabapentin, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
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.
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.
122 studies on the registry are indexed under Post-Dural Puncture Headache; 27 are open to participants now.
This study's planned enrollment of 75 is close to the median of 80 across 79 interventional studies indexed under Post-Dural Puncture Headache.
Browse Post-Dural Puncture Headache studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Theophylline
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.
Drug: Sumatriptan
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
Drug: Gabapentin
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.
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.
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
Severity of headache
Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.
Time frame: 24 hours after drug treatment.
Post-Dural Puncture Headache duration
Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3.
Time frame: 24 hours after drug treatment.
Length of hospital stay
Length of hospital stay will be recorded from the hospital admission till discharge.
Time frame: Till the discharge from the hospital (Up to 2 weeks)
Treatment-related side effects
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.
Time frame: 24 hours after drug treatment.
Total amount of rescue analgesia consumption
Total amount of rescue analgesia consumption will be measured.
Time frame: 24 hours after drug treatment.
Degree of patient satisfaction
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)
Time frame: 24 hours after drug treatment.
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
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Studies of the drugs tested here: Theophylline · Sumatriptan · Gabapentin
Post-Dural Puncture Headache →