Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Tramadol for Labor Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02999594
• Other study ID #: mamc123
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 2, 2016
• Last updated: December 22, 2016
• Start date: December 2016
• Est. completion date: May 2018

Study information

• Verified date: December 2016
• Source: Maulana Azad Medical College
• Contact: dr aastha raheja
• Phone: 8586032882
• Email: aastha_raheja2000[@]yahoo.com
• Is FDA regulated: No
• Health authority: India: central drugs standard control organisation
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tramadol for Labor Analgesia

Intervention

Drug:
• Tramadol Hydrochloride
50mg intramuscularly
• Distilled Water
2ml intramuscularly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maulana Azad Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analogue scale	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	Yes
Secondary	patient satisfaction	scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied	at the end of labor( within 12 hours)	No
Secondary	fetal distress	fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)	during labor	Yes
Secondary	duration of 1st and 2nd stage of labor		1st and 2nd stage	No
Secondary	women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness	increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol	till the end of labor	Yes
Secondary	neonatal safety in terms of apgar score and nicu admission		apgar score at 0 and 5 min	Yes
Secondary	need for caesarean section or instrumental delivery	emergency caesarean section or need for forceps or vacuum application	during labor	Yes