Tramadol for Labour Analgesia in Low Risk Primiparous Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-06-30

Brief Summary

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Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.

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Detailed Description

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Conditions

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Pain During Labour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tramadol

100 mg of tramadol SC (single dose) = 2 mL

Group Type EXPERIMENTAL

Tramadol

Intervention Type DRUG

100 mg of Tramadol was applied in the forearm SC (single dose).

Placebo

2 mL of a sterile solution SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 ml of a sterile solution was applied in the forearm SC (single dose).

Interventions

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Tramadol

100 mg of Tramadol was applied in the forearm SC (single dose).

Intervention Type DRUG

Placebo

2 ml of a sterile solution was applied in the forearm SC (single dose).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Gestational age between 37 and 40 6/7 weeks
* Primiparous patient
* Singleton
* 4 to 5 cms of dilation
* Intact membranes or spontaneous rupture of membranes less than 2 hours
* Fetus in a vertex presentation
* Gynecoid pelvis by clinical examination