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

Anne Louise de Barros Garioud1,2, Bettina Nygaard Nielsen1, Lars Falcon1

  • 1Department of Anesthesiology, Juliane Marie Center, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.

Acta Anaesthesiologica Scandinavica
|February 10, 2023
PubMed

Insights

This study investigated intravenous clonidine to prevent emergence agitation in infants aged 3-12 months. Results will inform the use of clonidine for preventing this common postoperative behavior in young children.

Area of Science:

  • Anesthesiology
  • Pediatric Medicine
  • Pharmacology

Background:

  • Emergence agitation is a frequent issue in children post-anesthesia.
  • Current evidence for clonidine's efficacy in infants is limited.
  • This study focuses on the youngest pediatric age group (3-12 months).

Purpose of the Study:

  • To evaluate the efficacy of intraoperative intravenous clonidine for preventing emergence agitation in infants.
  • To assess the safety profile of clonidine in this pediatric population.
  • To provide evidence for the use of clonidine in infants undergoing general anesthesia.

Main Methods:

  • Randomized, placebo-controlled, double-blind trial design.
  • Enrollment of 320 infants aged 3-12 months undergoing general anesthesia.
  • Intravenous administration of clonidine (3 μg/kg) or placebo ~20 minutes before procedure end.

Main Results:

  • Primary outcome: incidence of emergence agitation (Watcha scale >2).
  • Secondary outcomes: postoperative pain, nausea, vomiting, and safety composite.
  • Intention-to-treat population for primary analyses.

Conclusions:

  • The PREVENT AGITATION II trial aims to provide key data on clonidine's efficacy.
  • This research will contribute valuable knowledge on the safety of clonidine in infants.
  • Findings will help optimize anesthetic care for young children.
Abstract

Keywords:
clonidineemergence agitationinfantssevoflurane

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