NCT05108688

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache Following Obstetric Surgery Under Spinal Anesthesia: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Headache

Interventions

Type	Name	Description
DRUG	Mirtazapine	Mirtazapine 30 mg tablet once daily for 3 successive days
DRUG	Sumatriptan	Sumatriptan 50 mg tablet once daily for 3 successive days
OTHER	Placebo	Placebo tablets once daily for 3 successive days.

Timeline

• Start date: 2021-11-15
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2021-11-05
• Last updated: 2024-01-22

Locations

1 site across 1 country: Egypt