Unidad de Cuidados Intensivos Pediátricos y Unidad de Recuperación Postanestésica, Servicio de Pediatría, Instituto del Niño y del Adolescente, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), C/ Profesor Martin Lagos s/n, 28040, Madrid, Spain.
Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Trials. 2020 Jan 2;21(1):1. doi: 10.1186/s13063-019-3906-2.
Surgery can generate significant stress and anxiety in up to 70% of the paediatric population. There are several pharmacological and non-pharmacological strategies to reduce pre-operative anxiety in children, however, they have several side effects and the available information about them is contradictory. The role of clowns and hydroxyzine in the management of anxiety is controversial, with some studies supporting and others contraindicating both strategies.
We propose a randomised double-blind, controlled clinical trial that will evaluate the effectiveness of both interventions (hydroxyzine and clowns), alone or in combination, to reduce pre-operative anxiety (using the modified Yale scale of preoperative anxiety) in children aged 2-16 years undergoing outpatient surgery (n = 188). Subjects will be randomised into two groups - (1) standard procedure (parental accompaniment) combined with placebo or (2) standard procedure combined with preoperative hydroxyzine. After randomisation, they will be divided by chance into two further groups, depending on the presence of clowns on the patient's surgery day. Control of pre-operative anxiety will be determined in the four groups by a modified Yale scale of preoperative anxiety and cortisol levels. Compliance of children during induction of anaesthesia, time until anaesthesia recovery, presence of postoperative delirium and use of analgesia until discharge will be also assessed. For additional information, the children, parents and healthcare professionals involved in the study will complete a satisfaction survey.
This study aims to gather evidence on which of these four therapeutic options achieves the highest reduction of pre-operative anxiety with the best safety profile to allow paediatricians and anaesthesiologists to use the most effective and safe option for their patients.
ClinicalTrials.gov identifier: NCT03324828. Registered 21 September 2017.
手术会给高达 70%的儿科人群带来显著的压力和焦虑。有许多药理学和非药理学策略可以减少儿童术前焦虑，但它们都有一些副作用，并且关于它们的可用信息相互矛盾。小丑和羟嗪在焦虑管理中的作用存在争议，一些研究支持，而另一些研究则反对这两种策略。
我们提出了一项随机双盲对照临床试验，该试验将评估单独或联合使用两种干预措施（羟嗪和小丑）以降低接受门诊手术的 2-16 岁儿童术前焦虑（使用改良耶鲁术前焦虑量表）的效果（n=188）。受试者将被随机分为两组 - （1）标准程序（父母陪同）加安慰剂或（2）标准程序加术前羟嗪。随机分组后，他们将根据小丑是否出现在患者手术当天随机分为两组。通过改良耶鲁术前焦虑量表和皮质醇水平来确定四组儿童的术前焦虑控制情况。还将评估诱导麻醉期间儿童的配合度、麻醉恢复时间、术后谵妄的发生以及直至出院时使用的镇痛剂。为了获得更多信息，参与研究的儿童、父母和医护人员将完成满意度调查。
本研究旨在收集证据，以确定这四种治疗方案中的哪一种能最大限度地降低术前焦虑，同时具有最佳的安全性，以便儿科医生和麻醉师能够为其患者选择最有效和最安全的方案。
ClinicalTrials.gov 标识符：NCT03324828。注册于 2017 年 9 月 21 日。
