Skip to main content
OpenTrials
Completed

NCT Number: NCT05108688

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain-Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mirtazapine

Drug

Mirtazapine 30 mg tablet once daily for 3 successive days

Sumatriptan

Drug

Sumatriptan 50 mg tablet once daily for 3 successive days

Placebo

Other

Placebo tablets once daily for 3 successive days.

Primary outcomes

  1. Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 5, 2021
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.