Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

December 22, 2016 updated by: dr aastha raheja, Maulana Azad Medical College

Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tramadol
50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
Drug: Tramadol Hydrochloride
50mg intramuscularly
Placebo Comparator: distilled water
2ml distilled water intramuscularly will be used as a placebo.
Drug: Distilled Water
2ml intramuscularly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 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
at 2nd hour of administration

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maulana Azad Medical College

Investigators

  • Principal Investigator: dr aastha raheja, Maulana Azad Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 17, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mamc123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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