Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Phase 2

• Conditions: Tramadol for Labor Analgesia
• Interventions: Drug: Distilled Water; Drug: Tramadol Hydrochloride

• Registration Number: NCT02999594
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

Tramadol for labor analgesia: a low risk placebo controlled randomised control trial

Detailed Description

Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular route in a blinded manner. Visual analogue score will be assessed in the beginning and every hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-17
• Study First Posted: 2016-12-21
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-23
• Primary Completion: 2018-04
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• delivering for first time(nulliparous)
• well established labor ( 3 or more contractions in a span of ten minutes
• cervical dilation of 4 cm or more
• >= 80% effacement of cervix

Exclusion Criteria

• any medical disorder- diabetes,hypertension
• obstetric high risk factors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
distilled water	Distilled Water	2ml distilled water intramuscularly will be used as a placebo.
tramadol	Tramadol Hydrochloride	50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic

Primary Outcome Measures

Name	Time	Method
visual analogue scale	at 2nd hour of administration	visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration

Secondary Outcome Measures

Name	Time	Method
fetal distress	during labor	fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)
neonatal safety in terms of apgar score and nicu admission	apgar score at 0 and 5 min
patient satisfaction	at the end of labor( within 12 hours)	scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied
duration of 1st and 2nd stage of labor	1st and 2nd stage
women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness	till the end of labor	increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol
need for caesarean section or instrumental delivery	during labor	emergency caesarean section or need for forceps or vacuum application