| CTRI Number |
CTRI/2008/091/000264 [Registered on: 03/02/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
To find out whether low dose of Ketamine can provide effective and safe analgesia during labour. |
|
Scientific Title of Study
|
To evaluate the efficacy of low dose Ketamine in providing analgesia during labour. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sam Joel |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Anaesthesia
christian medical college
Vellore
TAMIL NADU
632004
India |
| Phone |
0416 2282105 |
| Fax |
|
| Email |
samcmc2002@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sam Joel |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Anaesthesia
christian medical college
Vellore
TAMIL NADU
632004
India |
| Phone |
0416 2282105 |
| Fax |
|
| Email |
samcmc2002@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sam Joel |
| Designation |
|
| Affiliation |
|
| Address |
Dept of Anaesthesia
christian medical college
Vellore
TAMIL NADU
632004
India |
| Phone |
0416 2282105 |
| Fax |
|
| Email |
samcmc2002@hotmail.com |
|
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Source of Monetary or Material Support
|
| Christian Medical college, Vellore |
|
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Primary Sponsor
|
| Name |
nil |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Sam Joel |
Labour room of Christian medical college |
Dept of Anaesthesia , Christian medical college-632004
Vellore
TAMIL NADU |
0416 2282105
samcmc2002@hotmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board, Christian Medical college,Vellore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain and analgesia during labour, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
0.4 mg/kg/hr over 30 min, 0.2 mg/kg/hr infusion |
| Comparator Agent |
Normal saline |
saline infusion at same rate |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
All parturient, with no antenatal risk factors and expected to have a normal vaginal delivery will be included in the study |
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| ExclusionCriteria |
| Details |
Women with cardiac disease, gestational hypertension, epilepsy, known psychiatric disorder, multifetal pregnancy, cephalopelvic disproportion and previous caesarean section will be excluded from the study. |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of low dose ketamine in providing obstetric analgesia |
10 point visual analogue scale |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To observe if this regimen has any side effects on the mother, the progress of labor and the fetus |
Mother- progress of labor,haemodynamic parameters, sedation, hallucinations and sleep disturbances. Baby- APGAR score at 1 and 5 minutes,the cord blood pH |
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Target Sample Size
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Total Sample Size="70"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The study is a double-blind, randomized controlled trial which will initially be conducted in the labour room of CMC hospital, Vellore. Full term, pregnant women expected to have normal vaginal delivery, with no antenatal risk factors will be included in the study. The procedure will be explained to the patient and a written consent obtained, following which they would be allotted randomly into two groups. When the patient enters the active phase of labour, one group will receive 0.4mg.kg-1 of ketamine intravenously over 30 min, followed by an infusion of 0.2mg.kg-1.hr-1 while those in the control group will receive an equivalent volume of Normal Saline. The rate of infusion may be reduced if the parturient is found to be too sedated. The rescue analgesic would be intramuscular injection of Pethidine (50mg) which would be available to all who need it after one hour of starting the infusion. The degree of analgesia will be evaluated, at regular intervals, on a 10 point visual analogue scale. The maternal and fetal haemodynamics and the progress of labor will be monitored continuously. The newborn will be assessed by the neonatologist / attending doctor and the APGAR score at 1 and 5 minutes will be noted, the cord blood pH will be analysed. The anticipated side effects of Ketamine will be monitored which include haemodynamic parameters, sedation, hallucinations and sleep disturbances. The mother and the newborn will be observed for 48 hrs after delivery. |