Does Intraoperative Clonidine Reduce Post Operative Agitation in Children?
Condition: Psychomotor Agitation
MeSH terms: Psychomotor Agitation
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Clonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injection - during surgery; Injection - during surgery
Other intervention name(s): catapresan; NaCl
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anaesthesia; Children; Clonidine; Sevoflurane; Postoperative agitation; Prevention; Pharmacokinetics; Safety