Comparison of analgesic effect of paracetamol versus pethidine in labor
Design
In this interventional study, 100 pregnant women who are candidates for natural childbirth will be selected and divided into two groups using block randomization method (n=50 in each group). Proper counseling will be done and a written informed consent will be obtained before starting the treatment regimen.
Settings and conduct
Upon starting the active phase of labor intervention group1 will receive intravenous Paracetamol 1g/6.7 ml (CaspianTamin Co.) and 1 ml intramuscular placebo injectionin and intervention group 2 will receive intramuscular Pethidine 50 mg/1 ml (CaspianTamin Co.) and 6.7 ml intravenous placebo injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 37 weeks pregnancy, first or second pregnancy, singleton. Exclusion criteria: Malpresentation of fetus، macrosomia.
Intervention groups
Intervention group 1: Intravenous Paracetamol 1g /6.7 ml (CaspianTamin Co.) and 1 ml intramuscular placebo injection. Intervention group 2: Intramuscular Pethidine 50 mg/1 ml (CaspianTamin Co.) and 6.7 ml intravenous placebo injection.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150808023559N17
Registration date:2018-03-24, 1397/01/04
Registration timing:prospective
Last update:2018-03-24, 1397/01/04
Update count:0
Registration date
2018-03-24, 1397/01/04
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-19, 1397/01/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of paracetamol versus pethidine in labor
Public title
Labor pain relief with paracetamol and pethidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 37 weeks pregnancy
First or second pregnancy
Singleton
Exclusion criteria:
Malpresentation of fetus
Macrosomia
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned randomly by blocking in one of the two specified groups and after selecting the envelope for each patient, before starting the treatment regimen envelope will be opened and based on the protocol, one of two methods will be selected.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and clinical caregivers are not aware of the type of medication
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.ARUMS.REC.1396.202
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O80, O84
ICD-10 code description
Delivery
Primary outcomes
1
Description
Pain
Timepoint
Before analgesic administrations and two times (30 and 60 min) after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
Apgar test
Intervention groups
1
Description
Intervention group: Intravenous Paracetamol 1g /6.7 ml (CaspianTamin Co.) and 1 ml intramuscular placebo injection
Category
Treatment - Drugs
2
Description
Intervention group: Intramuscular Pethidine 50 mg/1 ml (CaspianTamin Co.) and 6.7 ml intravenous placebo injection
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Farnaz Enamzade
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 4233 8888
Email
enamzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Masoud Entezari
Street address
Ardabil University of Medical Science, Daneshgah street, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 3352 2247
Email
m.entezari@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farnaz Enamzade
Position
Gynecology Asisstant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 4233 8888
Email
enamzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Noshin Mobaraki
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 4233 8888
Email
n.mobaraki@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farnaz Enamzade
Position
Gynecology Asisstant
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Alavi Hospital, Moadi street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5615783134
Phone
+98 45 4233 8888
Email
enamzade@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available