30 parturients were participated in a double blinded, cross-over study.
The patients were eligible for the study ,if they have singleton ASA1 pregnancies without complication such as pre eclampsia and if the fetus was in a normal cephalic presentation. patients were recruited during the active phase of labour when cervical dilatation was about 4-8 cm . the patients who were opium abuser, cigarette smoker or had history of chronic NSAIDS or analgesic drugs use, were excluded. After randomization the selected patients received the study medicines during two 30-min study periods with a 15-min wash-out sequence after each period.15 patients used
remifentanil and Entonox during the first period and entonox and sodium chloride 0.9% during the second while the reminder of the patients used the drugs in a reverse order.
Intravenous remifentanil with the loading dose of 0.25µg/kg and 0.025 µg/kg/min infusion from 0/5µg/cc solution for 30 minutes were used in this study, and 15 minutes lock-out intervals was given to them and then sodium chloride 0.9% is infused with the same rate for 30 minutes.
During the period of intravenous infusion , inhalant enthonox is used by parturients. The severity of uterine pain after each contraction, heart rate/ blood pressure, oxyhemoglobuline saturation and fetal heart rate were assessed every 5 minutes in parturients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104026115N1
Registration date:2012-08-14, 1391/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-14, 1391/05/24
Registrant information
Name
Mojtaba Rahimi Varposhti
Name of organization / entity
Esfahan medical university
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 1532
Email address
rahimi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding Remifentanil to Entonox in reducing labour pain in first stage of active phase of labour in parturients
Public title
The effect of adding Remifentanil to Entonox in reducing labour pain in first stage of active phase of labour in parturients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: samples are taken from the ASA1 term parturients؛ cephalic presentation who are in the active phase of labor (dilation 4-8 cm) and natural delivery.
Exclusion criteria: patients who do not have one of the interventional periods for any reasons (remifentanil and entonox)؛ have got serious complications that result cesarean section؛ NSAIDs and cigarette users.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Medical University
Street address
Hezar jerib street, Isfahan University of Medical Sciences, Daneshgah Ave.
City
Isfahan
Postal code
Approval date
2010-10-25, 1389/08/03
Ethics committee reference number
189057
Health conditions studied
1
Description of health condition studied
labour pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Labour pain
Timepoint
before intervention and after each contraction
Method of measurement
VAS
Secondary outcomes
1
Description
Sedation
Timepoint
Before and after intervention
Method of measurement
RAMSEY Score
2
Description
Nausea
Timepoint
Before and after intervention
Method of measurement
VAS
Intervention groups
1
Description
Intervention group: intravenous remifentanil (ultra short acting potent opioid) with the loading dose of 0.25µg/kg and 0.025 µg/kg/min infusion from 0/5µg/cc solution for 30 minutes were used and inhaled entonox in each contraction
Category
Treatment - Drugs
2
Description
Control group: Sodium chloride 0.9% is infused with the same rate for 30 minutes.During the each period of intravenous infusion , and inhaled entonox in each contraction
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaid Beheshti Hospital
Full name of responsible person
Naghmeh Ahmadi
Street address
Motahary street, Pol Felezy, Esfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery for Research Isfahan University of Medical Sciences.
Full name of responsible person
Dr Peiman Adibi
Street address
Hezar jerib street, Esfahan, Esfahan university of medical sciences
City
Isfahan
Grant name
189057
Grant code / Reference number
189057
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery for Research Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr Mojtaba Rahimi
Position
Assistant professor
Other areas of specialty/work
Street address
Hezar jerib street, Isfahan University of Medical Sciences.
City
Isfahan
Postal code
81745319
Phone
+98 31 1661 9661
Fax
Email
rahimi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Dr Mojtaba Rahimi
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar jerib street, Isfahan University of Medical Sciences
City
Isfahan
Postal code
81745319
Phone
+98 31 1661 9661
Fax
Email
rahimi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Naghmeh Ahmadi
Position
MD, Resident
Other areas of specialty/work
Street address
Hezar jerib street, Isfahan Medical University
City
Isfahan
Postal code
8168685591
Phone
+98 31 1668 8936
Fax
Email
na.ahmadi58@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)