Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901888984937 Date of Registration: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison between the Effect of Sumatriptan versus Naratriptan in Treatment of Post-dural Puncture Headache in Obstetric patients. A Randomized Controlled Trial.
Official scientific title Comparsion between the Effect of Sumatriptan versus Naratriptan in Treatment of Post-dural Puncture Headache in Obstetric patients. A Randomized Controlled Trial.
Brief summary describing the background and objectives of the trial Objective: This comparative study was designed to assess the efficacy of Naratriptan, a triptan that is used in management of migraine, and compare it with sumatriptan, a first generation triptan, in relieving post-dural puncture headache in parturients who gave birth by cesarean section under intrathecal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PDPH
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/03/2017
Actual trial start date 04/03/2017
Anticipated date of last follow up 31/08/2018
Actual Last follow-up date 05/09/2018
Anticipated target sample size (number of participants) 189
Actual target sample size (number of participants) 189
Recruitment status Completed
Publication URL no url
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sumatriptan Sumatriptan:100mg in the first day then 50 mg for two days 3 days therapeutic pain relief (PDPH) relief 63
Experimental Group Naratriptan 5mg in the fist day then 2.5 mg for the next two days 3 days pain (PDPH) RELIEF therapeutic 63
Control Group multivitamins placebo once daily 3 days control 63 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
parturients, who had cesarean section under spinal anesthesia ASA I/II and aged between 18-35 years and complained from moderate to severe PDPH after 25 gauge spinal needle puncture on second or third postoperative day were included in this study. Patients with a history of ischemic heart disease, pregnancy-induced hypertension (PIH), chronic hypertension cardiac, vascular liver and renal impairment, or any other severe or disabling medical condition were excluded. Individuals with a history of migraine headache , known hypersensitivity to study drugs, a previous inadequate response to at least two triptans, currently using ergotamine, monoamine oxidase inhibitors (MAO-inhibitors), or selective serotonin reuptake inhibitors (SSRI) were excluded as well. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/03/2017 Fayoum University Hospitals Ethical Committee
Ethics Committee Address
Street address City Postal code Country
University District Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pain score after 72 hours o. 6, 12,,24 ,48,72 hours
Secondary Outcome incidence of side effects no definite time but through the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospitals Fayoum District Fayoum 63514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
organization Fayoum University Hospitals Fayoum 63514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospitals University District Fayoum 63514 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Joseph Makram Botros 105 toman Bai Street, Zeitoun Cairo, Egypt Cairo 11321 Egypt
Atef Mohammad Sayed Mahmoud Khaleel Fayoum University Hospitals Fayoum 63514 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joseph Botros dr_jo27@yahoo.com 01227598825 105 Toman Bai street , Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Lecturer of Anesthesiology Faculty of Medicine Fayoum University Fayoum Egypt
Role Name Email Phone Street address
Public Enquiries Joseph Botros dr_jo27@yahoo.com 0127598825 105 Toman Bai Street , Zeitoun
City Postal code Country Position/Affiliation
Cairo 11321 Egypt Lecturer of Anesthesiology Faculty of Medicine Fayoum University Fayoum Egypt
Role Name Email Phone Street address
Scientific Enquiries Atef Sayed mygodprotection@yahoo.com 01016581609 University hospitals of Fayoum
City Postal code Country Position/Affiliation
Fayoum 63514 Egypt Fayoum University Faculty of Medicine Anesthesia Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information