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

Phase 4

• Conditions: eed for mechanical ventilation in post-surgical neonates; Need for mechanical ventilation in post-surgical neonates; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12609000875202
• Lead Sponsor: The Royal Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation measured in hours[Five days post-operative period]

Secondary Outcome Measures

Name	Time	Method
Impact on amplitude integrated electroencophalography (aEEG) of tramadol versus placebo. aEEG will be assessed visually with reader blinded to treatment group. Outcome is presence of seizure activity[aEEG will be recorded continuously until extubation.]