Back to resultsMirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache
Primary Purpose
Headache
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Mirtazapine
Sumatriptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Headache
Eligibility Criteria
Inclusion Criteria:
- ASA I and II Patients.
- Patients undergoing obstetric surgeries under spinal anesthesia. and complaining from moderate-to-severe PDPH after 25G 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.
Sites / Locations
- Ain-Shams University HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Mirtazapine Therapy group (M group)
Sumatriptan Therapy group (S group)
Control group ( C group)
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05108688
Brief Title
Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache
Official Title
Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache Following Obstetric Surgery Under Spinal Anesthesia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mirtazapine Therapy group (M group)
Arm Type
Active Comparator
Arm Title
Sumatriptan Therapy group (S group)
Arm Type
Active Comparator
Arm Title
Control group ( C group)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Description
Mirtazapine 30 mg tablet once daily for 3 successive days
Intervention Type
Drug
Intervention Name(s)
Sumatriptan
Intervention Description
Sumatriptan 50 mg tablet once daily for 3 successive days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets once daily for 3 successive days.
Primary Outcome Measure Information:
Title
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours
Description
Incidence of refractory headache ((number of patients)(n),% of patients) (refractory: failed intervention and conservative treatment) after 72 hours after intervention (Day 0)
Time Frame
72 hours after intervention (Day 0)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
Facility Information:
Facility Name
Ain-Shams University Hospitals
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Mamdouh Esmat
Phone
01001241928
Email
ibrahim_mamdouh@med.asu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache
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