Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05108688
• Other study ID #: FMASU MD 209/2021
• Status: Completed
• Phase: Phase 4
• Start date: November 15, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Mirtazapine
Mirtazapine 30 mg tablet once daily for 3 successive days
• Sumatriptan
Sumatriptan 50 mg tablet once daily for 3 successive days

Other:
• Placebo
Placebo tablets once daily for 3 successive days.

Locations

Country	Name	City	State
Egypt	Ain-Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)