Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Phase 4

Completed

• Conditions: Headache
• Interventions: Drug: Mirtazapine; Drug: Sumatriptan; Other: Placebo

• Registration Number: NCT05108688
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-05
• Study Start: 2021-11-15
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• ASA I and II Patients.
• Patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe PDPH after 25G or 27G spinal needle puncture.

Exclusion Criteria

• Refusal of the intervention or participation in the study.
• Patient under age of 18 years old.
• Psychiatric illness.
• Patients with a history of ischemic heart disease, pregnancy-induced hypertension, chronic hypertension, cardiac, vascular, liver or renal impairment.
• Patients with a history of migraine.
• Patients with known hypersensitivity to study drugs.
• Patients currently using ergotamine, monoamine oxidase inhibitors, or selective serotonin reuptake inhibitors.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirtazapine Therapy group (M group)	Mirtazapine	-
Sumatriptan Therapy group (S group)	Sumatriptan	-
Control group ( C group)	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours	72 hours after intervention (Day 0)	Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours after intervention (Day 0)

Trial Locations

Locations (1)

Ain-Shams University Hospitals; 🇪🇬 Cairo, Egypt