ANZICS CTG Endorsed Study
Baby SPICE
Sedation practice in paediatric intensive care in Australia and New Zealand
Study Description
Intravenous sedatives and analgesics are commonly administered to mechanically ventilated children, however there is substantial variability in sedation practices in different intensive care units and in different countries around the world. The BabySPICE pilot study will evaluate the hypothesis that a sedation regimen based on safe, light sedation with dexmedetomidine as the primary sedative agent and in which benzodiazepine use is minimised, will lead to improved patient centred outcomes. The purpose of the BabySPICE Pilot RCT is to obtain preliminary data on the feasibility and safety of conducting a study that tests this hypothesis.
This is a pilot prospective randomised controlled trial that will be conducted in six tertiary paediatric intensive care units in Australia and New Zealand and will recruit 60 patients with a maximum of 15 patients from each participating site. The study will recruit patients ventilated for less than 12 hours, who are expected to remain ventilated at least 24 hours after enrolment AND need immediate and ongoing sedation. Patients will be recruited into one of two study groups. The intervention arm will receive dexmedetomidine as the primary agent, with the addition of second line sedatives as required. The use of benzodiazepines in this arm will be minimized and clonidine will not be used concurrently with dexmedetomidine. The control arm will have sedation according to usual practice as chosen by the treating clinician. This may include the use of clonidine according to standard unit practice but can only include dexmedetomodine as a last resort if all other agents have failed. In both groups, the default sedation level is light sedation, as defined by a target State Behaviour Scale (SBS) of -1 to +1, unless otherwise specified by the treating clinician. The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (GpDex) and a ‘wildtype’ (usual practice) control group (GpStd) with respect to the proportion of patients achieving light sedation (SBS -1 to +1) in the first 48 hours of sedation in intensive care. Information from the Pilot RCT will be used to design a subsequent phase III trial.
Management Committee
Simon Erickson (Chair and Project Manager), Debbie Long, Tony Slater, Marino Festa, Johnny Millar, Carmel Delzoppo, John Beca, Brian Anderson, Claire Sherring, John Awad, Mary Lou Morritt, and Yahya Shehabi
Administering Institution
Perth Children’s Hospital, Perth
Collaborators
Hospira Ltd (Melbourne, Australia)
Sample Size
60 patients
Funding
Perth Children’s Hospital Foundation: $20,000 Pfizer Unrestricted Grant: $15,000
Reference
CTG1314-009
ACTRN12614000225617
Contact