Comparison of the prophylactic effect of Dexamethasone and Ondansetron versus placebo on pruritus due to intrathecal Sufentanil in painless labor: a double blind randomized clinical trial
Objectives: To compare the prophylactic effect of Dexamethasone and Ondansetron versus placebo on pruritus due to intrathecal Sufentanil in painless labor.
Design: A double blind randomized clinical trial.
Setting and conduct: The eligible pregnant women who will refer to Fatemieh Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 18 to 45 years; pregnant woman; prim gravida; gestational age of 30 to 40 weeks; enter active phase of labor.
Exclusion criteria: Need to emergency cesarean section; sensitivity to Ondansetron or Dexamethasone.
Intervention group 1: Intravenous injection of 2 ml Ondansetron (4 mg) single dose before labor.
Intervention group 2: Intravenous injection of 2 ml Dexamethasone (8 mg) single dose before labor.
Control group: Intravenous injection of 2 ml distilled water single dose before labor.
Primary outcome: Assessing pruritus every 15 minutes until labor using Visual Analog Scale (VAS).
Randomization: The patients will be randomly assigned to the intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of medication. The physician who will examine the patients will not be aware of the medication. Therefore, the trial will be run as double blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201709249014N189
Registration date:2017-10-02, 1396/07/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-02, 1396/07/10
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-12-30, 1395/10/10
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the prophylactic effect of Dexamethasone and Ondansetron versus placebo on pruritus due to intrathecal Sufentanil in painless labor: a double blind randomized clinical trial
Public title
Comparison of the prophylactic effect of Dexamethasone and Ondansetron versus placebo on pruritus due to intrathecal Sufentanil in painless labor
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age of 18 to 45 years; pregnant woman; prim gravida; gestational age of 30 to 40 weeks; enter active phase of labor.
Exclusion criteria: Need to emergency cesarean section; sensitivity to Ondansetron or Dexamethasone.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to the intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of medication. The physician who will examine the patients will not be aware of the medication. Therefore, the trial will be run as double blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.UMSHA.REC.1395.421
Health conditions studied
1
Description of health condition studied
Pruritus
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Assessing pruritus
Timepoint
every 15 minutes until labor
Method of measurement
Using Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Intravenous injection of 2 ml Ondansetron (4 mg) single dose before labor.
Category
Treatment - Drugs
2
Description
Intervention group 2: Intravenous injection of 2 ml Dexamethasone (8 mg) single dose before labor.
Category
Treatment - Drugs
3
Description
Control group: Intravenous injection of 2 ml distilled water single dose before labor.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Zeinab Ghanbari
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, Hamadan 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
Fatemieh Hospital
Full name of responsible person
Zeinab Ghanbari
Position
Medical Student
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
zeynab7001@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemieh Hospital
Full name of responsible person
Dr Pooran Hajian
Position
Anesthesiologist
Other areas of specialty/work
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Postal code
Phone
+98 81 3828 3939
Fax
Email
pooranhajian567@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)