Not Yet RecruitingPhase 4ACTRN12609000875202

The effect of tramadol analgesia on post-operative ventilation duration in post-surgical neonates

Impact on post-operative newborn infants receiving tramadol or placebo on duration of mechanical ventilation

Sponsor

The Royal Children's Hospital

Enrollment

100 participants

Start Date

Nov 1, 2009

Study Type

Interventional

Conditions

Need for mechanical ventilation in post-surgical neonates

Summary

Tramadol is increasingly used as an analgesic in newborn infants who require surgery. It is hypothesised that tramadol use promotes decreased exposure to other analgesic agents like morphine, some of which depress respiration. By measuring the effect of tramadol or placebo on duration of mechanical ventilation, we can determine whether or not using tramadol has a significant sparing effect for the use of opioid analgesic agents.

Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 4 Weekss

Plain Language Summary

Simplified for easier understanding

This study investigates whether the pain medication tramadol can reduce the time newborn babies need to be on a breathing machine after surgery. It is for newborn infants up to 4 weeks old who require surgery and are in a neonatal intensive care unit.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Administration of tramadol infusion 2 mg/kg (in 10 mls) every six hours for five days commencing immediately post-operatively.

Locations(1)

Australia

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ACTRN12609000875202