Not Yet RecruitingPhase 2ACTRN12614000225617

Sedation Practice in Intensive Care: A randomised controlled pilot study

A randomised controlled pilot trial of early goal-directed sedation in paediatric intensive care.


Sponsor

Australia and NewZealand Intensive Care-Research Centre (ANZIC-RC)

Enrollment

60 participants

Start Date

Apr 1, 2014

Study Type

Interventional

Conditions

Summary

This pilot study aims to evaluate the feasibility of conducting a large scale multicentre RCT in paediatric intensive care, comparing current sedation practice with a dexmedetomidine based sedation regimen that minimizes benzodiazepines.


Eligibility

Sex: Both males and femalesMin Age: 0 DayssMax Age: 15 Yearss

Inclusion Criteria3

  • Children requiring sedation to facilitate mechanical ventilation in intensive care.
  • Subject has been mechanically ventilated for less than 12 hours
  • Patient is expected to remain mechanically ventilated for more than 24 hours

Exclusion Criteria15

  • Age 16 years or older
  • Proven or suspected acute primary brain lesion that may result in global impairment of conscious level or cognition, such as traumatic brain injury, intracranial haemorrhage, intracranial infection or hypoxic brain injury.
  • Proven or suspected neurological injury or pathology that may result in permanent or prolonged weakness of upper and lower limbs.
  • Burn injuries
  • Receiving or expected to need continuous neuromuscular blockade
  • Allergy to dexmedetomidine
  • Cardiovascular instability as manifested by any of the following:
  • a. Mean arterial blood (MAP) pressure less than 2 standard deviations below the normal mean for age despite resuscitation and vasopressor therapy
  • b. Heart rate (HR) less than 2 standard deviations below normal for age
  • c. Atrio-ventricular block (2nd or 3rd degree) in the absence of a functioning pacemaker
  • End stage liver failure or acute fulminant hepatic failure
  • A history of a chronic brain process that has resulted in severe global impairment of conscious level or cognition, and may include CP, metabolic conditions, and progressive neurological disorders
  • Patient is on ECLS
  • Death is deemed imminent and inevitable
  • There is an underlying disease that makes survival to 90 days unlikely

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Early goal directed sedation consisting of a dexmedetomidine based sedation protocol: The primary sedative agent in the intervention arm is dexmedetomidine delivered by continuous infusion without a

Early goal directed sedation consisting of a dexmedetomidine based sedation protocol: The primary sedative agent in the intervention arm is dexmedetomidine delivered by continuous infusion without a loading dose, supplemented by alternative sedative agents as outlined below, to achieve the level of sedation specified by the treating clinician. Effective pain relief is provided by an infusion or boluses of an opioid (eg morphine or fentanyl) or other agent (eg ketamine) at the discretion of the treating clinician. This is particularly important during painful or noxious procedures (eg. endotracheal suction) Dexmedetomidine arm [known as GpDex]: refer to study algorithm Commence dexmedetomidine infusion at 1.0 mcg/kg/hr without a loading dose. This will take about 45 minutes to produce full sedative effect. Dexmedetomidine infusion will be titrated to sedative effect up to a maximum dose of 1.4 mcg/kg/hr (depending on age: 0-1 yrs 1.0 micrograms/kg/hour, 1-5 years 1.4 mcg/kg/hr, 5-10 years 1.3 mcg/kg/hr, >10 years 1.0 mcg/kg/hr) with dose of infusion specified by the treating clinician to achieve the desired level of sedation specified by the treating clinician. a) Dexmedetomidine infusion will be continued until sedation is no longer required to a maximum of 14 days after enrolment. 2) Boluses or infusion or both of opioids, as chosen by the treating clinician, will be administered, if required, at a dose specified by the treating clinician to provide analgesia 3) Alternative sedative agents may be considered if a combination of dexmedetomidine and opioid infusions do not provide sufficient sedation. Examples include ketamine, chloral hydrate, sedating anti-histamines, phenobarbitone as per physician preference 4) Supplemental propofol can be used (up to a maximum of 24 hours and a maximum dose of 4 mg/kg/hr, in accordance with individual intensive care unit policy), always at the lowest effective dose to: a) Provide sedation during commencement and initial titration of dexmedetomidine infusion b) To optimise sedation to achieve the level of sedation specified by the treating clinician at any time when dexmedetomidine alone and at maximum dose is insufficient to provide patient comfort and safety c) Provide rescue sedation for immediate control of sudden agitation at any time d) Provide additional sedation during procedures 5) Benzodiazepines (such as midazolam, diazepam and clonazepam) may be administered if sufficient level of sedation is not attained with the above measures. 6) Clonidine should not be administered concurrently with dexmedetomidine (although may used to prevent or treat suspected dexmedetomidine withdrawal).


Locations(5)

Princess Margaret Hospital - Subiaco

NSW,QLD,WA,VIC, Australia

Royal Children's Hospital - Herston

NSW,QLD,WA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,WA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,WA,VIC, Australia

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000225617