Remifentanil is one of drugs for controlling labor pain. Despite numerous studies, researchers have not reached a consensus at the method and dose of remifentanil administration. In this study, we will compare two different methods of remifentanil administration (incremental bolus and incremental infusion) in controlling labor pain and the effect on length of labor in the stage I and II. The aim of this study is to find an appropriate method to relieve labor pain which has maximum analgesic effect in minimum dose and not to make labor prolong. In this randomized, single-blind clinical trial, 82 primigravid pregnant women, with gestational age of 37-42 weeks and dilation ≥3cm or more, are randomly assigned in two groups of 41. Remifentanil is administered by bolus for one group and in continuous infusion for another group. Pain severity, whole dose of remifentanil administration in each patient, the duration of labor, and the newborn Apgar scores will be compared in these two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100811020N2
Registration date:2013-02-18, 1391/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-18, 1391/11/30
Registrant information
Name
Maryam Khoshideh
Name of organization / entity
Tehran University of Medical Sciences, Arash Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 0909
Email address
khooshide@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2012-01-23, 1390/11/03
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Incremental Bolus and Infusion Administration of Remifentanil on Labor Pain and Length of Delivery Time in Women During Labor.
Public title
Effect of different methods of remifentanil administration in labor pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: primigravid healthy parturient with 37-42 weeks of pregnancy; in active stage of labor (uterine contraction 3 per 10 minutes, lasting for 30 to 40 seconds and cervical dilation >=3 cm); with vertex presentation. Exclusion criteria: parturient with positive history of preeclampsia; using psychiatric drugs; using opioid and alcohol; antenatal hemorrhage; fetal distress; BMI>30 or <20; multi tone and requesting for epidural analgesia.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Dr Hesabi Sq.
City
Zahedan
Postal code
Approval date
2010-11-07, 1389/08/16
Ethics committee reference number
87-1804
Health conditions studied
1
Description of health condition studied
Single spontaneous delivery
ICD-10 code
O80
ICD-10 code description
cases with minimal or no assistance, with or without episiotomy
Primary outcomes
1
Description
severity of uterine contractions pain
Timepoint
Every 15 minutes from the onset of active phase of labor to delivery
Method of measurement
verbal numeric rating scale (VNRS)
2
Description
first stage of labour duration
Timepoint
every 15 minutes in first stage of labour from 4 cm dilation up to 10 cm, and in second stage from 10 cm dilation up to delivery.
Method of measurement
Time by minutes
Secondary outcomes
1
Description
grading of sedation
Timepoint
every 15 minutes
Method of measurement
Modified Observer's Assessment of Alertness
Intervention groups
1
Description
If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group A, remifentanil (in method of incremental infusion) will be prescribed from 0.025 microgram per kg of body weight of the patients in minute and If needed its dose gradually increases to 0.05, 0.075, and 0.1.
For preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms per milliliter).
Category
Treatment - Drugs
2
Description
If the intensity of pain reaches to 7 or more (based on verbal numeric grading criteria) in group B, remifentanil (in method of incremental bolus) will be prescribed in dose of 0.25 microgram per kg, and If needed another bolus will be received in dose of 0.5 microgram per kg. lockout time between two boluses was 4 minutes. For preparing, 1 mg remifentani is diluted into 100 ml of normal saline in solution (concentration of 10 micrograms.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abitaleb Hospital
Full name of responsible person
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences, Deputy of Research
Full name of responsible person
Dr. Hamidreza Mahmoodzade-sagheb
Street address
Deputy of Research, University of Medical Sciences, Dr hesabi Sq.,
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences, Deputy of Research