Efficacy of Entonox and Dexamethasone with Remifentanil and Dexamethasone in Controlled Pain.
Design
Control group clinical trial, with parallel, double-blind, randomized groups.
Settings and conduct
Ardebil Alavi Hospital
Participants/Inclusion and exclusion criteria
The study participants were the first pregnant mothers.
Intervention groups
In this study, 100 pregnant women were randomly assigned into A and B groups among first pregnant women referred to Hospital.
Main outcome variables
Promote painless delivery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044865N1
Registration date:2019-12-30, 1398/10/09
Registration timing:retrospective
Last update:2019-12-30, 1398/10/09
Update count:0
Registration date
2019-12-30, 1398/10/09
Registrant information
Name
Zahra Asdagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 937 688 4241
Email address
zahra.asdagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Entonox and Dexamethasone versus Remifentanil and Dexamethasone on the control of painless delivery
Public title
Comparison effect of Entonox and Dexamethasone
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
First Pregnancy
Term pregnancy
Without illness
Exclusion criteria:
preterm laber
multipar
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is randomized blocking. Patients in groups A and B are placed in quadratic blocks (two patients in group A and two patients in group B). There will be a draw and the blocks will continue to be completed until the number of samples is 100.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants, clinical outcome evaluator caregivers are kept blind. And they have no information about whether or not to take the medicine.
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
Shahid Motahhari Street, Alavi Hospital
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.ARUMS.REC.1398.248
Health conditions studied
1
Description of health condition studied
Painful delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain score
Timepoint
30, 60, 120, 180 minutes
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group (A): This group includes pregnant women receiving entonox and dexamethasone. In this group, after reaching the active phase of labor, the patient is advised to inhale one or two puffs of Entonex gas by mask each time he / she is given 8 mg of dexamethasone at the same time as Entonox gas.
Category
Treatment - Drugs
2
Description
Second Intervention Group (B): This group includes pregnant women receiving remifentanil and dexamethasone. In this group, after reaching the active phase of delivery, dexa metazone is administered 8 mg intravenously, along with remifentalin opioid administered by the pain pump at a concentration of 1.5 mg per 100 ml serum at 14 cc / h. Starts.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alavi Hospital
Full name of responsible person
Giti Rahimi
Street address
Shahid Motahari Street
City
Ardebil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
zahra.asdagh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
شهاب بهلولی
Street address
Shahid Motahhari Street, Alavi Hospital
City
Ardebil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
zahra.asdagh@gmail.com
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
Zahra Asdagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Motahhari Street, Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
Email
zahra.asdagh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Zahra Asdagh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Motahhari Street, Alavi Hospital
City
Ardabil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Fax
Email
zahra.asdagh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Zahra Asdagh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Motahhari Street, Alavi Hospital
City
Ardebil
Province
Ardabil
Postal code
5613974156
Phone
+98 45 3324 8888
Email
zahra.asdagh@gmail.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