Pediatric anesthesia & critical care
Clonidine for preventing emergence agitation in infants (PREVENT AGITATION II): Protocol and statistical analysis plan
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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