Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-12-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison Of Different Doses Of Intrathecal Neostigmine In Prevention Of Post-Dural Puncture Headache

NCT04905953

Headache

UNKNOWN PHASE2/PHASE3

Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache

NCT04257851

Post-Dural Puncture Headache

COMPLETED PHASE4

Comparison of Drugs on Headache Treatment After ECT Treatment

NCT03830398

Mental Disorders

UNKNOWN PHASE4

Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache

NCT03997006

Post-Dural Puncture Headache

COMPLETED PHASE4

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

NCT04069897

Migraine Disorders

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mirtazapine Therapy group (M group)

Group Type ACTIVE_COMPARATOR

Mirtazapine

Intervention Type DRUG

Mirtazapine 30 mg tablet once daily for 3 successive days

Sumatriptan Therapy group (S group)

Group Type ACTIVE_COMPARATOR

Sumatriptan

Intervention Type DRUG

Sumatriptan 50 mg tablet once daily for 3 successive days

Control group ( C group)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets once daily for 3 successive days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mirtazapine

Mirtazapine 30 mg tablet once daily for 3 successive days

Intervention Type DRUG

Sumatriptan

Sumatriptan 50 mg tablet once daily for 3 successive days

Intervention Type DRUG

Placebo

Placebo tablets once daily for 3 successive days.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No