The appearance of pruritus is frequent after use of intrathecal morphine, especially after cesarean section. This pruritus is often difficult to treat and responds poorly to conventional treatments to comparing the prophylactic effect of intravenous ondansetron and granisetron on pruritus after intrathecal morphine in elective cesarean surgery, in randomized, double‐blind clinical study 90 pregnant women that candidate for elective caesarean section with intrathecal morphine entered the study. Patients were divided into three groups, and the same procedure was performed to spinal anesthesia. Before spinal anesthesia group one received 8 mg ondansetron, group two received 3mg granisetron and group 3 received 4mg normal salin. After operative, pruritus were assessed with a visual analog scale
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014092219252N1
Registration date:2014-10-05, 1393/07/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-05, 1393/07/13
Registrant information
Name
Sara Kohani
Name of organization / entity
Ahwaz Jondishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6504
Email address
kohani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jondishapour University of Medical Sciences
Expected recruitment start date
2014-03-12, 1392/12/21
Expected recruitment end date
2014-07-12, 1393/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Prophylactic Effect of Intravenous Ondansetron And Granisetron On Pruritus after Intrathecal Morphine in Elective Cesarean Surgery
Public title
Effect of Ondansetron and Granisetron For The Prevention Of Pruritus In Patients Undergoing Cesarean Section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Women undergoing elective cesarean section with spinal anesthesia. Exclusion criteria: Drug addiction; history of allergy to ondansetron, granisetron and morphine; electrolyte abnormalities; history of pruritic skin diseases and other systemic diseases.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences
Street address
Ethics Committee of Ahwaz Jondishapour University Of Medical Sciences, Golestan Blvd., Ahwaz
City
Ahwaz
Postal code
Approval date
2014-05-07, 1393/02/17
Ethics committee reference number
ajums.REC.1393.176
Health conditions studied
1
Description of health condition studied
Pruritus
ICD-10 code
L29.9
ICD-10 code description
Pruritus, unspecified
Primary outcomes
1
Description
pruritus
Timepoint
3, 6 and 18 hour after intrathecal morphine
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Group1: injection 8 mg ondansetron before intrathecal morphine
Category
Prevention
2
Description
Group2: injection 3mg granisetron before intrathecal morphine
Category
Prevention
3
Description
Group3: injection 4mg normal salin before intrathecal morphine
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Sara Kohani
Street address
Emam Khomeini Hospital, Shahid Ahvazian, Ahvaz
City
Ahwaz
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Sara Kohani
Street address
Razi Hospital, Felestin St, Ahvaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Reza Malekzadeh
Street address
Ahwaz Jondishapour University of Medical Sciences, Golestan BLvd., Ahwaz
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jondishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Sara Kohani
Position
Resident Of Anesthesiology
Other areas of specialty/work
Street address
Golestan Blvd., Ahwaz Jondishapour University of Medical Sciences, ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1221 6504
Fax
Email
Kohani.sarah@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jondishapour University of Medical Sciences
Full name of responsible person
Mohammad Reza Gousheh
Position
Anesthesiologist
Other areas of specialty/work
Street address
Golestan Blvd., Ahwaz Jondishapour University of Medical Sciences, Ahwaz
City
Ahwaz
Postal code
Phone
+98 61 1221 6504
Fax
Email
rgousheh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pain Research Center
Full name of responsible person
Sanaz Nazari
Position
Anesthesia Technician
Other areas of specialty/work
Street address
Golestan BLvd., Ahwaz Jondishapour University Of Medical Sciences, Ahwaz
City
Ahwaz
Postal code
Phone
00
Fax
Email
s.nz1990@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)