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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000875202

Enrollment

100

Registered

2009-10-07

Start date

2009-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 4 Weeks

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results