Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Maulana Azad Medical College

Status and phase: Unknown; Phase 2

Conditions: Tramadol for Labor Analgesia

Treatments: Drug: Distilled Water; Drug: Tramadol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02999594

mamc123

Details and patient eligibility

About

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

Full 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

Enrollment: 86 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

tramadol

Experimental group

Description:

50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic

Treatment:

Drug: Tramadol Hydrochloride

distilled water

Placebo Comparator group

Description:

2ml distilled water intramuscularly will be used as a placebo.

Treatment:

Drug: Distilled Water