Comparison of the effect pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women
To assess the effect of pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Fatemieh Hospital in Hamadan city on 111 eligible primiparous women. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Term pregnancy
A singleton with a cephalic display
Cervical dilatation 4 cm
Pregnant women undergoing induction of labor with oxytocin
Exclusion criteria:
Analgesic consumption in the last 24 hours
Preeclampsia and eclampsia
Severe obesity
Intrauterine fetal death
Fetal abnormalities
Intervention groups
Intervention group 1:
Infusion of one gr of paracetamol plus 100 ml of normal saline over 20 minutes
Intervention group 2:
Infusion of 25 mg of pethidine plus 100 ml of normal saline over 20 minutes
Intervention group 3:
Infusion of one gr of paracetamol and 25 mg of pethidine plus 100 ml of normal saline over 20 minutes
Main outcome variables
Primary outcome:
Labor pain intensity
The level of satisfaction
Secondary outcome:
Side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N455
Registration date:2022-12-29, 1401/10/08
Registration timing:prospective
Last update:2022-12-29, 1401/10/08
Update count:0
Registration date
2022-12-29, 1401/10/08
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
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women
Public title
Comparison of the effect pethidine, paracetamol and their combination on the reduction of labor pain and the level of satisfaction of primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 40 years
Term pregnancy
A singleton with a cephalic display
Cervical dilatation 4 cm
Pregnant women undergoing induction of labor with oxytocin
Exclusion criteria:
Analgesic consumption in the last 24 hours
Preeclampsia and eclampsia
Severe obesity
Intrauterine fetal death
Fetal abnormalities
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
111
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare three sheets of paper, writing on one sheet the name of the intervention 1 and on another sheets the name of the intervention 2 and on the third sheet the name of the intervention 3. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The three paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
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 and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-09-10, 1401/06/19
Ethics committee reference number
IR.UMSHA.REC.1401.509
Health conditions studied
1
Description of health condition studied
Labor pain
ICD-10 code
O75.0
ICD-10 code description
Maternal distress during labor and delivery
Primary outcomes
1
Description
Labor pain intensity
Timepoint
In the first and fifth minutes after delivery
Method of measurement
Using visual analog scale (VAS)
2
Description
The level of satisfaction
Timepoint
After the third stage of labor
Method of measurement
Using McKay's satisfaction questionnaire
Secondary outcomes
1
Description
Side effects (nausea, vomiting, maternal tachycardia, respiratory depression, drowsiness, itching)
Timepoint
In the first, second and third stage of labor
Method of measurement
With clinical examination and history taking
Intervention groups
1
Description
Intervention group 1: Infusion of one gr of paracetamol plus 100 ml of normal saline over 20 minutes
Category
Treatment - Drugs
2
Description
Intervention group 2: Infusion of 25 mg of pethidine plus 100 ml of normal saline over 20 minutes
Category
Treatment - Drugs
3
Description
Intervention group 3: Infusion of one gr of paracetamol and 25 mg of pethidine plus 100 ml of normal saline over 20 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital in Hamadan city
Full name of responsible person
Dr Hamideh Parsapour
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3828 3939
Email
h.parsapour@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamideh Parsapour
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
h.parsapour@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Hamideh Parsapour
Position
Gynecologist
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
h.parsapour@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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