Psychomotor Agitation Clinical Trial
Official title:
Does Intraoperative Clonidine Reduce Post Operative Agitation in Children Anaesthetised With Sevoflurane? A RCT Including Pharmacokinetic Investigation.
Clonidine is widely used off-label in children for several indications. Clonidine is used for
treatment and/or prevention of postoperative agitation in children anaesthetised with
Sevoflurane. The investigators don´t have solid evidence for the effect and the investigators
don´t have data for characterization of the pharmacokinetic profile among age-groups for
children 1-6 years.
In this study the investigators want to investigate if IV Clonidine administered at the end
of surgery can prevent/reduce postoperative agitation. Secondary outcomes include
measurements of postoperative pain relief and adverse effects, including a 30-day follow-up.
BACKGROUND:
Clonidine is widely used off-label in children for several indications such as treatment
and/or prevention of postoperative agitation when anaesthetised with Sevoflurane. However,
the current level of evidence in support of Clonidine treatment for postoperative agitation
in children remains limited. In addition, the pharmacokinetic profile of intravenous
Clonidine in children is not well characterized for age-groups.
METHODS/DESIGN:
In this prospective multicentre double-blinded randomized clinical trial, the investigators
aim to investigate the impact of intravenous (IV) Clonidine administered at the end of
surgery, on the incidence and degree of postoperative agitation. Children will be assigned to
either the intervention or the placebo group. The allocation will be carried out centrally
and stratified based on age and trial-site, with152 patients allocated to each group. In the
intervention group, 3 micrograms per kg of IV clonidine is administered approximately 20
minutes before the expected completion of the surgery (as assessed by the surgeon). In the
control group; Saline (placebo) is injected in equal quantity during surgery at the same
time. The drugs are concealed in identical blinded ampoules.
The primary outcome is postoperative agitation measured on the Watcha scale. Secondary
outcomes include measurements of postoperative pain relief and adverse effects, including
30-day follow-up.
Twenty of the patients age 1-2 years and twenty age >2 years, with a peripheral venous access
in place, will be allocated to drug assay sampling; enabling a compartmental PK analysis
based on age group, using non-linear mixed effects models.
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