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Tramadol for Labour Analgesia in Low Risk Primiparous Women

NCT01889979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-07-09

No results posted yet for this study

Summary

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.

Conditions

  • Pain During Labour

Interventions

DRUG

Tramadol

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Saint Thomas Hospital, Panama

    lead OTHER

Principal Investigators

  • Osvaldo Reyes, MD · Saint Thomas Maternity Hospital

  • Riggie Castillo, MD · Saint Thomas Maternity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-05-31
Completion
2013-06-30

Countries

  • Panama

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01889979 on ClinicalTrials.gov