Abstract

Anxiety in pediatric patients may challenge perioperative anesthesiology management and worsen postoperative outcomes. Sedative drugs aimed to reducing anxiety are available with different pharmacologic profiles, and there is no consensus on their effect or the best option for preschool children. In this study, we aimed to compare the effect of three different premedications on anxiety before anesthesia induction in preschool children aged 2-6years scheduled for elective surgery. The secondary outcomes comprised distress during peripheral catheter (PVC) insertion, compliance at anesthesia induction, and level of sedation. In this double-blinded randomized clinical trial, we enrolled 90 participants aged 2-6years, who were scheduled for elective ear-, nose-and-throat surgery. The participants were randomly assigned to three groups: those who were administered 0.5mg/kg oral midazolam, 4µg/kg oral clonidine, or 2µg/kg intranasal dexmedetomidine. Anxiety, distress during PVC insertion, compliance with mask during preoxygenation, and sedation were measured using the modified Yale Preoperative Anxiety Scale, Behavioral Distress Scale, Induction Compliance Checklist, and Ramsay Sedation Scale, respectively. Six children who refused premedication were excluded, leaving 84 enrolled patients. At baseline, all groups had similar levels of preoperative anxiety and distress. During anesthesia preparation, anxiety was increased in the children who received clonidine and dexmedetomidine; however, it remained unaltered in the midazolam group. There were no differences in distress during PVC insertion or compliance at induction between the groups. The children in the clonidine and dexmedetomidine groups developed higher levels of sedation than those in the midazolam group. In preschool children, midazolam resulted in a more effective anxiolysis and less sedation compared to clonidine and dexmedetomidine.

Highlights

  • Anxiety in pediatric patients may challenge perioperative anesthesiology management and worsen postoperative outcomes

  • These results are in contrast to studies from Fazi et al, and Kumari et al, showing that the midazolam was superior in reducing anxiety as compared to clonidine[11] and dexmedetomidine.[12]

  • The children that received midazolam had no increase in anxiety from baseline until anesthesia preparation, while the children in both the clonidine and dexmedetomidine groups experienced an increase in anxiety

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Summary

Introduction

Anxiety in pediatric patients may challenge perioperative anesthesiology management and worsen postoperative outcomes. Midazolam has untoward side effects with increased risk of respiratory depression, amnesia, and paradoxical reactions.[4] Two alpha-­2-­agonists, clonidine and dexmedetomidine, have emerged as alternatives to midazolam These drugs have good sedative, analgesic, and anxiolytic properties with minimal respiratory depression and better perioperative hemodynamic stability.4-­6 Among these two alpha-­2-­agonists, clonidine has been used more frequently.[6] One major downside of clonidine is a longer duration of onset, requiring administration 60 min before anesthesia induction.[7] Compared with clonidine, dexmedetomidine has been suggested to have a more favorable safety profile, with anxiolysis and sedation achieved in 40 min following intranasal administration.[8] There are only a few published randomized controlled studies using validated tools for the measurement of preoperative anxiety in preschool children, comparing the effect of dexmedetomidine, clonidine and midazolam. A validation study showed that in children aged 5−12 years, an mYPAS score >30 for anxiety had a positive predictive value of 79%, which corresponded to an STAI-­CH score of >37, with only 6% false-­positives and 4% false-­negatives.[18]

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