Comparison of analgesic effect of remifentanil with and without dexamethasone 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 group will receive intravenous Remifentanil 0.05 μg/kg/min (Tofigh Daru Co.) and 8 mg intravenous Dexamethasone (once, 2 cc, Irandaroo Co.) injection and control group receive intravenous Remifentanil 0.05 μg/kg/min (Tofigh Daru Co.) and placebo (distilled water, 2 cc, Irandaroo Co., once) injection.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 37 weeks pregnancy, first or second pregnancy, singleton. Exclusion criteria: Malpresentation of fetus، macrosomia.
Comparison of analgesic effect of remifentanil with and without dexamethasone in labor
Public title
Labor pain relief with remifentanil
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
2
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.1396.189
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