Aims
We aim to evaluate the usefulness of intra-operatively administered clonidine in preventing emergence agitation in infants aged 3-12 months.
Significance
Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation may cause self-injury of the child, accidental removal of intravenous catheters or dressings, supplemental sedative drugs, extra nursing care, and additional time in the recovery room. It is not possible to extrapolate dose recommendations and results from the PREVENT AGITATION trial to children under 1 year due to developmental factors. Thus, a clinical trial investigating the effect of clonidine on emergence agitation, postoperative pain, and PONV in children <1 year is needed.
Hypothesis
Children aged 3-12 months receiving an intraoperative dose of 3mcg/kg clonidine will experience reduced emergence agitation, as measured by the Watcha scale, in comparison to placebo.
Objectives
The primary objective of this study is to evaluate the efficacy of clonidine for the prevention of emergence agitation. Secondary objectives of this study are to evaluate clonidine’s effects on opioid use and early post-operative vomiting, and to evaluate a composite safety outcome.
Methods
A randomised placebo-controlled trial in 320 children aged 3-12 months of age. Patients will be recruited 1:1 into two groups and randomly allocated to receive clonidine 3mcg/kg over 5mins or isotonic saline approximately 20 minutes prior to finishing surgery.
Likely benefits of the research
Children receiving clonidine are likely to experience decreased emergence agitation, decreased postoperative pain and vomiting, and decreased need of supplemental opioid in the post anaesthesia care unit. Furthermore, reducing the need for extra nursing care and additional time spent in PACU would improve the child’s and parents overall experience of their hospital stay as well as reduce burden on clinical staff and systems.
Associate Professor David Sommerfield, Perth Children’s Hospital, Western Australia;
Associate Professor Arash Afshari, Copenhagen University Hospital, Denmark.
The project was awarded A$70,000 funding through the ANZCA research grants program for 2024.