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), Madrid, Spain.
Departamento de Pediatría, Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain.
Biomed Res Int. 2021 Nov 11;2021:7394042. doi: 10.1155/2021/7394042. eCollection 2021.
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 ( = 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 ( = 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).
手术会导致 70%的儿科患者产生显著的术前焦虑（POA）。羟嗪和小丑等分散注意力的技术在焦虑管理中的作用存在争议。我们的主要目标是评估羟嗪对 POA 控制的影响。次要目标是评估羟嗪和分散注意力技术的潜在附加效果。我们对 2 至 16 岁接受门诊手术的儿童（n=165）进行了一项随机双盲、对照临床试验。受试者被随机分配到羟嗪组（第 1 组）或安慰剂组（第 2 组）。为了次要目标，通过随机分配进一步将两组分为羟嗪加小丑陪伴组（第 3 组）和安慰剂加小丑组（第 4 组）。所有患者都按标准程序由父母陪同。POA 通过改良耶鲁 POA 量表（m-YPAS）确定。还评估了麻醉诱导期间儿童的依从性（诱导依从性检查表（ICC））。通过 m-YPAS 测量诱导时的 POA 控制，各组之间没有差异（=0.788）（第 1 组：39.2±27.9；第 2 组：37.0±26.1；第 3 组：34.7±25.5；第 4 组：32.4±20.5）。不同治疗组之间的 ICC 水平没有差异（第 1 组：1.8±3.4；第 2 组：1.5±3.0；第 3 组：1.2±2.4；第 4 组：1.5±2.7）。所有治疗的组合（第 3 组）是控制焦虑进展的唯一有效策略。总之，羟嗪对控制儿童 POA 无效。羟嗪和小丑的组合避免了我们患者的 POA 进展。该试验已在 ClinicalTrials.gov 注册，标识符为：NCT03324828（于 2017 年 9 月 21 日注册，2018 年 1 月 12 日开始招募受试者）。
