Pediatric anesthesia & critical care

Clonidine for preventing emergence agitation in infants (PREVENT AGITATION II): Protocol and statistical analysis plan

Acta Anaesthesiol ScandPublished Protocol and statistical analysis plan of a randomised controlled trial

Study context

Population
Infants aged 3–12 months scheduled for GA maintained with sevoflurane and opioidplanned enrolment
Participants
320 infants
Planned comparison
IV clonidine 3 μg/kg vs placebo ≈20 min before end of surgery
Primary endpoint
Incidence of emergence agitation (any Watcha score >2) during PACU stay
Methodological detailsplacebo-controlled, double-blind, parallel, stratified randomisation (age group, sex, site), Primary analyses in the ITT population per the Statistical Analysis Plan
  • Placebo-controlled
  • Double-blind
  • Parallel
  • Stratified randomisation (age group, sex, site)
  • Primary analyses in the ITT population per the Statistical Analysis Plan

No results yet. This paper sets out the design of a trial; its results are to come.

Original publication

Clonidine for preventing emergence agitation in infants (PREVENT AGITATION II): Protocol and statistical analysis plan. Acta Anaesthesiol Scand. Published 27 February 2023. doi:10.1111/aas.14212

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