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Trial registered on ANZCTR


Registration number
ACTRN12610000079044
Ethics application status
Approved
Date submitted
4/01/2010
Date registered
22/01/2010
Date last updated
22/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Synergistic effect of Clonidine on sedation requirements in Paediatric Intensive Care (PICU)
Scientific title
In children ventilated in Paediatric Intensive Care (PICU), does clonidine added to standard sedation, when compared to control, provide a statistically significant reduction in overall consumption of standard sedation.
Universal Trial Number (UTN)
U1111-1113-1164
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sedation in critical illness 256460 0
Condition category
Condition code
Anaesthesiology 256629 256629 0 0
Other anaesthesiology
Respiratory 256630 256630 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clonidine infusion 0.25-2 mcg/kg/hr in addition to standard sedation -morphine/midazolam infusions

The 'study drug' (clonidine/control) is started at 0.25mcg/kg/hr and increased in hourly increments of 0.25mcg/kg/hr as per study protocol. These increments occur over a 12 hour period, after which time the study drug is maintained, and the patient is actively weaned from morphine and midazolam over the next five 24 hour periods (or until discharge, whichever is sooner). This again follows a protocol which allows a 5% reduction in morphine and midazolam every 2 hours. The study drug is continued for this time, and then weaned by 0.25-0.75mcg/kg/hr per hour, after six 24hour periods, or once ready for extubation (whichever is sooner).
Intervention code [1] 255750 0
Treatment: Drugs
Comparator / control treatment
standard sedation - morphine/midazolam infusions + placebo (normal saline)

As described above, the patient is initially commenced on standard sedation with morphine and midazolam for a 12 hour period. After this time, the 'study drug' is started, and incrementally increased for the next 12 hours to a maximum of 2mcg/kg/hr. For the next five 24 hour periods(or until ready for extubation), the study drug remains at this rate, while the morphine and midazolam are actively weaned by 5% every 2 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 257521 0
Overall daily consumption of morphine and midazolam (mcg/kg/day)

This is documented as hourly and daily totals in digital nursing records
Timepoint [1] 257521 0
per day, for duration of PICU stay
Primary outcome [2] 257522 0
overall sedation score by assessment of the State Behavioural Score (SBS).
Timepoint [2] 257522 0
for duration of PICU stay

This outcome is documented as daily running total in digital records.
Secondary outcome [1] 262744 0
length of stay (days)
Timepoint [1] 262744 0
for duration of PICU stay
Secondary outcome [2] 262745 0
ventilator hours
Timepoint [2] 262745 0
for duration of PICU stay

Eligibility
Key inclusion criteria
patients admitted to PICU during study enrollment period, expected to be ventilated for greater than 24 hours
Minimum age
1 Months
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Ventilated less than 24 hours
2. Pre or post-op condition or morbidity precludes the use of the study drug.
3. Hypotension
4. Status Epilepticus
5. Non-pharmacological Coma/ encephalopathy
6. Renal Failure defined as
(a)Creatinine Clearance (CrCl)<10ml/min
(b)requiring Renal Replacement
Therapy (RRT)
(c) End Stage Renal Failure (ESRF)

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)
Patients can be enrolled any time from admission to 96 hours. Eligible patients should be identified as soon as possible and parents consented after being given time to read the parent consent information. Once enrolled, the nurse looking after the patient picks up a numbered pack/envelope with a study details. Blinding allocation will be in a separate white envelope within the pack, to be opened by the unblinded staff member making up the infusion
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random sequence generation using excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256227 0
Hospital
Name [1] 256227 0
Queensland Health -Royal Childrens Hospital
Country [1] 256227 0
Australia
Primary sponsor type
Individual
Name
Alana Kirkwood
Address
c/o PICU
RCH
Herston Road
Herston
4006
QLD
Country
Australia
Secondary sponsor category [1] 251561 0
None
Name [1] 251561 0
Address [1] 251561 0
Country [1] 251561 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258324 0
Queensland Childrens Health Services District(RCH) Ethics Committee
Ethics committee address [1] 258324 0
Level 3
Foundation Building
Royal Childrens Hospital
Herston Road
Herston
QLD
4029
Ethics committee country [1] 258324 0
Australia
Date submitted for ethics approval [1] 258324 0
Approval date [1] 258324 0
30/11/2009
Ethics approval number [1] 258324 0
HREC/09/QRCH/105

Summary
Brief summary
This is a trial aiming to assess how effective a drug called clonidine is in sedating children in intensive care. Children are normally kept asleep with morphine and midazolam, both sedative drugs with side effects like tolerance and withdrawl. Clonidine acts as a sparing agent, reducing the need for these drugs, and reducing the chance of side effects. This trial aims to show that by using clonidine, we allow a significant reduction in use of morphine and midazolam, and therefore a reduction in side effects. By showing this, we aim to encorporate Clonidine into normal sedation practice, improving our safe practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30653 0
Address 30653 0
Country 30653 0
Phone 30653 0
Fax 30653 0
Email 30653 0
Contact person for public queries
Name 13900 0
Dr Alana Kirkwood
Address 13900 0
c/o PICU
Level 2 surgical building
Royal Childrens Hospital
Herston Road
Herston
4006, QLD
Country 13900 0
Australia
Phone 13900 0
+61 447563301
Fax 13900 0
Email 13900 0
[email protected]
Contact person for scientific queries
Name 4828 0
Dr Alana Kirkwood
Address 4828 0
c/o PICU
Level 2 surgical building
Royal Childrens Hospital
Herston Road
Herston
4006, QLD
Country 4828 0
Australia
Phone 4828 0
+61 447563301
Fax 4828 0
Email 4828 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.