drugset / Trial / NCT05108688

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

NCT05108688

Phase 4 Completed 210 enrolled Ain Shams University
RandomizedParallel-groupDouble-blindTreatment

Summary

Postdural puncture headache (PDPH) is a potential complication after spinal anesthesia caused by traction on pain-sensitive structures from low cerebrospinal fluid pressure (intracranial hypotension) following a leak of cerebrospinal fluid at the puncture site. Symptoms of this condition include a bilateral frontal or occipital headache that is worse in the upright position, along with nausea, neck pain, dizziness, visual changes, tinnitus, hearing loss, or radicular symptoms in the arms. This study will examine the efficacy of mirtazapine in in the treatment of PDPH after obstetric surgery under spinal anesthesia and compared its efficacy with that of sumatriptan.

Timeline

Start
2021-11-15
Primary completion
2023-12-20
Completion
2023-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mirtazapine Other / unclassified 30 mg
Comparator Sumatriptan Unknown 50 mg

Indications