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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911743087495 Date of Approval: 11/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Prophylactic Intravenous Ondansetron to Reduce Pruritis after Intrathecal Fentanyl among Patients Undergoing Elective Cesarean Section in Worabe Comprehensive Specialized Hospital Southern Ethiopia, 2019.
Official scientific title Effectiveness of Prophylactic Intravenous Ondansetron to Reduce Pruritis after Intrathecal Fentanyl among Patients Undergoing Elective Cesarean Section in Worabe Comprehensive Specialized Hospital Southern Ethiopia, 2019.
Brief summary describing the background and objectives of the trial Background: Pruritus is the most common side effect of opioids which is characterized by an unpleasant, localized or generalized sensation on the skin accounts for 30-100%. Despite the various trials to prevent or treat pruritus, it remains a challenge and inconsistent results are published. Objectives: To assess the effectiveness of prophylactic intravenous ondansetron to reduce pruritus after intrathecal fentanyl among patients undergoing elective cesarean section in Worabe Comprehensive Specialized Hospital, Southern Ethiopia, 2019.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PONV Postoperative Nausea Vomiting NS Normal Saline IV Intra Venou
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 20/10/2019
Actual trial start date 25/10/2019
Anticipated date of last follow up 30/11/2019
Actual Last follow-up date 30/12/2019
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL http://www.pactr.org/
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ondansetron 8 milligram of Ondansetron 3 month Eight milligram intravenous ondansetron will be given before 30 minute of anesthesia induction 50
Control Group Normal saline placebo 4 milliliter of normal saline placebo 3 month 4 mililitere normal saline placebo will be given before 30 minute 50 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I ASA II parturient aged>18 years old Patients who refused to participate in the study History of a disorder associated with pruritus Patients having fentanyl allergy Patients with known allergy to ondansetron Patients who have existing itching with unknown cause Patients who took IV opioid and ondansetron preoperatively Patients having preexisting pregnancy induced pruritus Patients with complicated pregnancy Adult: 19 Year-44 Year 18 Year(s) 45 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 24/09/2018 Ethical board of Dilla University
Ethics Committee Address
Street address City Postal code Country
Dilla Dilla 11129029 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pruritus 30minute,2hour and 6hour
Secondary Outcome severity,onset and duration of pruritus 30 minute,2 hour and 6 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Worabe comprehensive specialized hospital siltie worabe 11132651 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdi Hulchafo Saliya worabe worabe 11132651 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor worabe comprhensive specialized hospital siltie worabe 11132651 Ethiopia Hospital
COLLABORATORS
Name Street address City Postal code Country
Sileshi Abiy Dilla Dilla 11129029 Ethiopia
Shukralla Shifa siltie worabe 11132651 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Abdi Hulchafo abdihulchafo4@gmail.com +25120516573 siltie
City Postal code Country Position/Affiliation
worabe 11132651 Ethiopia MSc Anesthetist
Role Name Email Phone Street address
Scientific Enquiries Abdi Hulchafo abdihulchafo4@gmail.com +251120516573 Worabe
City Postal code Country Position/Affiliation
Worabe 11132651 Ethiopia MSc Anesthetist
Role Name Email Phone Street address
Public Enquiries Shukralla Shifa shikshif1@gmail.com +25116362524 siltie
City Postal code Country Position/Affiliation
worabe 11132651 Ethiopia MPH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Some of our Individual Participant Data are available Informed Consent Form,Statistical Analysis Plan,Study Protocol December/2019 we can access through email address
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.pactr.org/ 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