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

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

Inclusion Criteria1

  • Newborn infants requiring surgery at The Royal Children's Hospital who are inpatients on the Newborn Intensive Care Unit.

Exclusion Criteria1

  • Infants born less < 32 weeks' gestation or infants with congenital malformations of the nervous system.

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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.

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