To find out whether low dose of Ketamine can provide effective and safe analgesia during labour.

Phase 2

• Conditions: Pain and analgesia during labour

• Registration Number: CTRI/2008/091/000264

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.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

All parturient, with no antenatal risk factors and expected to have a normal vaginal delivery will be included in the study.

Exclusion Criteria

Women with cardiac disease, gestational hypertension, epilepsy, known psychiatric disorder, multifetal pregnancy, cephalopelvic disproportion and previous caesarean section will be excluded from the study.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of low dose ketamine in providing obstetric analgesia	10 point visual analogue scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Labour room of Christian medical college; 🇮🇳 Vellore, TAMIL NADU, India

Labour room of Christian medical college

🇮🇳Vellore, TAMIL NADU, India

Dr. Sam Joel

Principal investigator

samcmc2002@hotmail.com