Abstract
Surgical procedures can generate significant preoperative anxiety (POA) in as much as 70% of the paediatric population. The role of hydroxyzine and distractive techniques such as clowns in the management of anxiety is controversial. Our main objective was to evaluate the effect of hydroxyzine on the control of POA. The secondary objective was to assess the potential additive effect of hydroxyzine and distracting techniques. We performed a randomized double-blind, controlled clinical trial in children aged 2–16 years undergoing outpatient surgery (n = 165). Subjects were randomized to hydroxyzine (group 1) or placebo (group 2). For the secondary objective, two further groups were made by allocation by chance to hydroxyzine plus accompaniment with clowns (group 3) and placebo plus clowns (group 4). All patients were accompanied by their parents as the standard procedure. POA was determined by a modified Yale scale of POA (m-YPAS). Compliance of children during induction of anesthesia (Induction Compliance Checklist (ICC)) was also assessed. No differences (p = 0.788) were found in POA control at the time of induction measured by m-YPAS (group 1: 39.2 ± 27.9; group 2: 37.0 ± 26.1; group 3: 34.7 ± 25.5; group 4: 32.4 ± 20.5). No differences were found in the level of ICC between the different treatment arms (group 1: 1.8 ± 3.4; group 2: 1.5 ± 3.0; group 3: 1.2 ± 2.4; group 4: 1.5 ± 2.7). The combination of all treatments (group 3) was the only effective strategy to contain the progression of anxiety. In conclusion, hydroxyzine was not effective to control POA in children. The combination of hydroxyzine and clowns avoided the progression of POA in our patients. This trial is registered with ClinicalTrials.gov identifier: NCT03324828 (registered 21 September 2017, subject recruitment started on 12th January 2018).
Highlights
Anxiety in children triggered by a scheduled surgical intervention is a major issue due to its frequency, in as much as 70% of the paediatric population, with short, medium, and long-term consequences [1,2,3,4,5].The need to have specific programs to reduce the anxiety of children is of special interest if we consider the adverse effects of surgery associated with high preoperative anxiety (POA) [3,4,5,6,7,8]
The declaration of the COVID-19 global pandemic forced the premature ending of the study, and the objective sample size was only reached in groups 1 and 2
Our results show that this pharmacological intervention alone does not modify POA
Summary
Anxiety in children triggered by a scheduled surgical intervention is a major issue due to its frequency, in as much as 70% of the paediatric population, with short-, medium-, and long-term consequences [1,2,3,4,5].The need to have specific programs to reduce the anxiety of children is of special interest if we consider the adverse effects of surgery associated with high preoperative anxiety (POA) [3,4,5,6,7,8]. High levels of POA are responsible for increased surgical morbidity [3], postoperative analgesia needs [4], and increased number of days of hospitalization and rate of complications [1]. To reduce POA, strategic programs that try to minimize the emotional impact have been designed. Some of these strategies are parental accompaniment during induction of anesthesia [6, 7], sedative premedication [8], and distraction techniques [9,10,11,12], including the presence of clowns [13] or music therapy [14]
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