Aim of this study is comparison of Ketamine infusion versus spinal analgesia for pain control in painless labor
Design
100 patients admitted for normal delivery to Taleghani hospital in Arak are included. Patients are divided into two groups randomly by random numbers table.
Settings and conduct
100 patients admitted for normal delivery to Taleghani hospital in Arak are included. Patients are divided into two groups randomly by random numbers table.This study is clinical trials and double blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: single pregnancy, cephalic embryo, gestational age is equal to or greater than 37 weeks
Exclusion criteria: Sensitivity to ketamine, dissatisfaction
Intervention groups
100 patients admitted for normal delivery to Taleghani hospital in Arak are included. Patients are divided into two groups.In the ketamine group, 0.2 mg of ketamine per kg of maternal weight gain begins with infusion simultaneously with the onset of active phase and continues until the end of delivery and the baby leaves the cervix. In the Spinal Group, patients receive 100 micro gram fentanyl distilled water to 5 milliliter.
Main outcome variables
Pain, motor block level and sensory block
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180614040095N1
Registration date:2018-07-28, 1397/05/06
Registration timing:registered_while_recruiting
Last update:2018-07-28, 1397/05/06
Update count:0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Soumayeh Nikfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
s.nikfar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-05, 1397/02/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Ketamine infusion versus spinal analgesia for pain control in painless labor
Public title
Comparison of Ketamine infusion versus spinal analgesia for pain control in painless labor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy
Cephalic embryo
Gestational age is equal to or greater than 37 weeks
Exclusion criteria:
Sensitivity to ketamine
Dissatisfaction
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number in division of groups in two groups A and B.Randomized patients are divided into two groups.Randomized allocation in clinical trial studies refers to the process of dividing participants into different groups randomly. Randomizing gives each participant equal odds for being placed in each of the groups. The candidate patients who enter the study are randomly assigned to the randomly assigned table of randomly assigned to the two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer are blind (double blind).Outcome elevator and analyzer don't aware from grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Arak University Of Medical Sciences
Intervention group: In the ketamine group, 0.2 mg of ketamine per kg of maternal weight gain begins with infusion simultaneously with the onset of active phase and continues until the end of delivery and the baby leaves the cervix.
Category
Treatment - Drugs
2
Description
Intervention group: In the Spinal Group, patients receive 100 μg fentanyl distilled water to 5 cc.