RT Journal Article
T1 Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
A1 Aleo Luján, Esther
A1 Picado, Amanda López
A1 Abancens, Belén Joyanes
A1 Soto Beauregard, María Del Carmen
A1 Tur Salamanca, Nuria
A1 Esteban Polonios, Carmen
A1 Torrejón, María José
A1 Perrino, Carlos González
A1 Rivas Paterna, Ana Belén
A1 Arias, Eva
A1 Rodríguez, Diamelis
A1 Rivas, Mª. Ángeles
A1 Rojo, Marina Laura Rodríguez
A1 García, Patricia Fernández
A1 Alarcón, Jaime Rodríguez
A1 San Pedro de Urquiza, Borja
AB 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).
PB John Wiley and Sons Ltd
SN 2314-6133
YR 2021
FD 2021-11-11
LK https://hdl.handle.net/20.500.14352/123519
UL https://hdl.handle.net/20.500.14352/123519
LA eng
NO Aleo E, Picado A, Abancens BJ, Soto Beauregard C, Tur Salamanca N, Esteban Polonios C, et al. Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial. BioMed Research International. 2021;2021.
NO El estudio fue financiado por recursos departamentales y por el premio 'IDC Salud − Calidad y Seguridad del Paciente
DS Docta Complutense
RD 3 sept 2025