Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000875202
Ethics application status
Approved
Date submitted
7/10/2008
Date registered
7/10/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of tramadol analgesia on post-operative ventilation duration in post-surgical neonates
Scientific title
Impact on post-operative newborn infants receiving tramadol or placebo on duration of mechanical ventilation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Need for mechanical ventilation in post-surgical neonates 3799 0
Condition category
Condition code
Other 3980 3980 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of tramadol infusion 2 mg/kg (in 10 mls) every six hours for five days commencing immediately post-operatively.
Intervention code [1] 3520 0
Treatment: Drugs
Comparator / control treatment
normal saline placebo administered intravenously 10 mls given every six hours for five days, commenced post-operatively
Control group
Placebo

Outcomes
Primary outcome [1] 4882 0
Duration of mechanical ventilation measured in hours
Timepoint [1] 4882 0
Five days post-operative period
Secondary outcome [1] 8239 0
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
Timepoint [1] 8239 0
aEEG will be recorded continuously until extubation.

Eligibility
Key inclusion criteria
Newborn infants requiring surgery at The Royal Children's Hospital who are inpatients on the Newborn Intensive Care Unit.
Minimum age
0 Hours
Maximum age
4 Weeks
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants born less < 32 weeks' gestation or infants with congenital malformations of the nervous system.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4039 0
Self funded/Unfunded
Name [1] 4039 0
Country [1] 4039 0
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
Flemington Road
PARKVILLE
VIC 3052
Country
Australia
Secondary sponsor category [1] 3574 0
None
Name [1] 3574 0
Address [1] 3574 0
Country [1] 3574 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6059 0
Human Research and Ethics Committee
Ethics committee address [1] 6059 0
The Royal Children's Hospital
Flemington Road
PARKVILLE
VIC 3052
Ethics committee country [1] 6059 0
Australia
Date submitted for ethics approval [1] 6059 0
15/08/2008
Approval date [1] 6059 0
15/09/2008
Ethics approval number [1] 6059 0
#28088

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29013 0
Address 29013 0
Country 29013 0
Phone 29013 0
Fax 29013 0
Email 29013 0
Contact person for public queries
Name 12170 0
Dr Rod Hunt
Address 12170 0
C/- Dept of Neonatal Medicine
The Royal Children's Hospital
FLemington Road
PARKVILLE
VIC 3052
Country 12170 0
Australia
Phone 12170 0
+61 3 9345 5008
Fax 12170 0
+61 3 9345 5067
Email 12170 0
[email protected]
Contact person for scientific queries
Name 3098 0
Dr Rod Hunt
Address 3098 0
C/- Dept of Neonatal Medicine
The Royal Children's Hospital
FLemington Road
PARKVILLE
VIC 3052
Country 3098 0
Australia
Phone 3098 0
+61 3 9345 5008
Fax 3098 0
+61 3 9345 5067
Email 3098 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.