Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

NCT05108688 | Completed Phase 4

• 1 other identifier: FMASU MD 209/2021
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Mirtazapine Therapy group (M group)

ACTIVE COMPARATOR

Drug: Mirtazapine

Sumatriptan Therapy group (S group)

ACTIVE COMPARATOR

Drug: Sumatriptan

Control group ( C group)

PLACEBO COMPARATOR

Other: Placebo

Interventions

Mirtazapine DRUG

Mirtazapine 30 mg tablet once daily for 3 successive days

Mirtazapine Therapy group (M group)

Sumatriptan DRUG

Sumatriptan 50 mg tablet once daily for 3 successive days

Sumatriptan Therapy group (S group)

Placebo OTHER

Placebo tablets once daily for 3 successive days.

Control group ( C group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Headache

Interventions

Mirtazapine; Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia and Intensive Care Department, Faculty of Medicine, Ain- shams University, Cairo, Egypt.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 5, 2021
• Study Start: November 15, 2021
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

EG (1)