Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study

Wolf A, McKay A, Spowart C, Granville H, Boland A, Petrou S, Sutherland A, Gamble C
Record ID 32010000360
English
Authors' objectives: Evaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam.
Authors' recommendations: Clonidine is an alternative to midazolam. Our trial-based economic evaluation suggests that clonidine is likely to be a cost-effective sedative agent in the PICU in comparison with midazolam (probability of cost-effectiveness exceeds 50%). Rebound hypertension did not appear to be a significant problem with clonidine but, owing to its effects on heart rate, specific cardiovascular attention needs to be taken during the loading and early infusion phase. Neither drug in combination with morphine provided ideal sedation, suggesting that in unparalysed patients a third background agent is necessary. The disappointing recruitment rates reflect a reluctance of parents to provide consent when established on a sedation regimen, and reluctance of clinicians to allow sedation to be studied in unstable critically ill children. Future studies will require less exacting protocols allowing enhanced recruitment.
Details
Project Status: Completed
URL for project: http://www.hta.ac.uk/1613
Year Published: 2014
URL for published report: http://www.journalslibrary.nihr.ac.uk/hta/hta18710/#/abstract
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: England, United Kingdom
MeSH Terms
  • Child
  • Child, Preschool
  • Hypnotics and Sedatives
  • Infant
  • Intensive Care Units, Pediatric
  • Midazolam
  • Preanesthetic Medication
Contact
Organisation Name: NIHR Health Technology Assessment programme
Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK
Contact Name: journals.library@nihr.ac.uk
Contact Email: journals.library@nihr.ac.uk
Copyright: <p>2010 Queen's Printer and Controller of HMSO</p>
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