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

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.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Drug: Mirtazapine; Drug: Sumatriptan; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mirtazapine Therapy group (M group)	Drug: Mirtazapine; Mirtazapine 30 mg tablet once daily for 3 successive days
Active Comparator: Sumatriptan Therapy group (S group)	Drug: Sumatriptan; Sumatriptan 50 mg tablet once daily for 3 successive days
Placebo Comparator: Control group ( C group)	Other: Placebo; Placebo tablets once daily for 3 successive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours	Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours after intervention (Day 0)	72 hours after intervention (Day 0)

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Vasoconstrictor Agents; Adrenergic alpha-2 Receptor Antagonists; Mirtazapine; Sumatriptan
• Other Study ID Numbers: FMASU MD 209/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No