PedPreMed: An RCT comparing three different agents as premedication for children 2-6 years old
Preoperative anxiety among children has been linked to negative consequences throughout the perioperative process. The study intends to compare the effect of three different soothing drugs administrated to pediatric patients before surgery.
To be anaesthetized can be an earth-shaking experience both for the child and for the parents. Sedatives given before the anaesthesia might decrease both agitation and anxiety. This study compares three different medications given one hour before anaesthesia with modern anaesthetic agents. Are there any differences between the medications regarding preoperative anxiety, hemodynamic effects during anaesthesia, anxiety, agitation, pain and vomiting postoperatively, and behavioural changes two weeks following the anaesthesia? This is a blinded, randomized and controlled trial.
Head of project
Magnus HultinAssociate professor, senior consultant (attending) physician
Preoperative anxiety in children is associated with many negative consequences and outcomes. Besides a complicated induction, anxiety in the child can result in severe behavioral changes in the postoperative course. According to studies non-pharmacological interventions have a moderate effect in reducing anxiety, thus premedication is established as an important part of the treatment for children who must undergo surgery. The goal of premedication is to relieve anxiety and provide sedation without negative hemodynamic influence and without prolonging the child's recovery from anesthesia. The ideal premedication to children in terms of safety and efficiency, is still debated. Today there are knowledge gaps with few studies comparing the efficacy between established and new premedications in children, and studies are completely lacking where these are examined in relation to total intravenous anesthesia.
The aim of this study is to compare the effect of midazolam, clonidine and dexmedetomidine given to children as soothing drug before surgery. In this randomized, controlled and blinded phase II study, 300 children, ages from 2-6, scheduled for ear, nose and throat surgery at Sunderby hospital, will be selected and observed from the day of surgery until two weeks postoperatively. The children are randomized to one of three groups, receiving one of the premedications that are included in the study. Effects of the premedications are assessed with regard to preoperative anxiety, level of sedation, intraoperative hemodynamic effects and postoperative recovery profile.