Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Headache

Treatments: Other: Placebo; Drug: Sumatriptan; Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT05108688

FMASU MD 209/2021

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 3 patient groups, including a placebo group

Mirtazapine Therapy group (M group)

Active Comparator group

Treatment:

Drug: Mirtazapine

Sumatriptan Therapy group (S group)

Active Comparator group

Treatment:

Drug: Sumatriptan

Control group ( C group)

Placebo Comparator group

Treatment:

Other: Placebo