The objective of this randomized clinical trial is to compare the effect of remifentanil plus ketamine and remifentanil alone in pain relief during labour. A total of 40 women were recruited and randomly allocated into one of the following groups. The parturients in one receive a bolus dose of remifentanil 25 mg and continous infusion of 0.06 g/kg/min remifentanil and 0.5 mg/kg/h ketamine for 4 hours (maximum dose of ketamine 2mg/kg) via pump. The parturients in another group receive a bolus dose of remifentanil 25 mg and continous infusion of 0.06 mg/kg/min remifentanil. Pain relief during labor from active phase until labour is measured by using VAS score as the primary outcome. The overall effective analgesia by Likert Scale, arterial blood pressure, heart rate, Spo2, respiratory rate, observer sedation score and fetal heart rate, and presence or absence of nausea and vomiting are recorded and compared between the two groups as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108241952N3
Registration date:2011-12-16, 1390/09/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-16, 1390/09/25
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-01-23, 1389/11/03
Expected recruitment end date
2011-12-30, 1390/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Continous infusion of Remifentanil and Ketamine compared with continous Remifentanil for pain relief in labour
Public title
Pain relief in laour with remifentanil and ketamine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous, ASA I, II, gestational age 38-42 weeks in early labour
Exclusion criteria: weight less than 50 kg more than 100 kg, candidate to undergo epidural analgesia, multifetus pregnancy, pre-eclampsia, premature labour, allergy to any agent under investigation, history of alcohol or drug abuse, psychiatric disorder
from active labor phase (cervical dilation 4-5 cm) until labour
Method of measurement
VAS score
Secondary outcomes
1
Description
heart rate
Timepoint
every 30 minutes
Method of measurement
pulse-oximetry
2
Description
SPO2
Timepoint
every 30 minutes
Method of measurement
pulse-oximetry
3
Description
respiratory rate
Timepoint
every 30 minutes
Method of measurement
visual monitoring
4
Description
fetal heart rate
Timepoint
every 30 minutes
Method of measurement
surface ultrasound
5
Description
present or absent of nausea and vomiting
Timepoint
every time is peresent
Method of measurement
visual monitoring and patient's saying
6
Description
Overall effective analgesia
Timepoint
every 30 minutes after statring analgesia
Method of measurement
VAS score
7
Description
arterial pressure
Timepoint
every 30 minutes after statrting analgesia
Method of measurement
non-invasive arterial presssure monitoring
Intervention groups
1
Description
Intervention group: a bolus dose of remifentanil 25 mg and continous infusion of 0.06 µg/kg/min remifentanil and 0.5 mg/kg/h ketamine for 4 hours (maximum dose of ketamine 2mg/kg) via pump. After four hours if delivery did not happen, we continue only remifentanil with the same dose.
Category
Treatment - Drugs
2
Description
Control group: a bolus dose of remifentanil 25 mg and continous infusion of 0.06 mg/kg/min remifentanil.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arash Women's Hospital
Full name of responsible person
Dr Ashraf Moini
Street address
Tehran University of Medical Sciences, Arash women’s Hospital, Rashid Ave., Resalat Highway, Tehranpars. P.O. Box: 1653915981
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arash Women's Hospital
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Ashraf Moini
Position
Associate Professor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Arash women’s Hospital, Rashid Ave., Resalat Highway, Tehranpars, Tehran, Iran. P.O. Box: 1653915981
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
a_moini@royaninstitute.org
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Nasrin Faridi
Position
Assistant Professor, MD
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Arash women’s Hospital, Rashid Ave., Resalat Highway, Tehranpars. P.O. Box: 1653915981
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
nfaridi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Eslami
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
bita_i2001@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)