Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial

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...

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Autores: Aleo Luján, Esther, Picado, Amanda López, Abancens, Belén Joyanes, Soto Beauregard, María Del Carmen, Tur Salamanca, Nuria, Esteban Polonios, Carmen, Torrejón, María José, Perrino, Carlos González, Rivas Paterna, Ana Belén, Arias, Eva, Rodríguez, Diamelis, Rivas, Mª. Ángeles, Rojo, Marina Laura Rodríguez, García, Patricia Fernández, Alarcón, Jaime Rodríguez, San Pedro de Urquiza, Borja
Formato: artículo
Fecha de publicación:2021
País:España
Recursos:Universidad Complutense de Madrid (UCM)
Repositorio:Docta Complutense
Idioma:inglés
OAI Identifier:oai:docta.ucm.es:20.500.14352/123519
Acesso em linha:https://hdl.handle.net/20.500.14352/123519
Access Level:acceso abierto
Palavra-chave:61
Ciencias Biomédicas
3299 Otras Especialidades Médicas
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spelling Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical TrialAleo Luján, EstherPicado, Amanda LópezAbancens, Belén JoyanesSoto Beauregard, María Del CarmenTur Salamanca, NuriaEsteban Polonios, CarmenTorrejón, María JoséPerrino, Carlos GonzálezRivas Paterna, Ana BelénArias, EvaRodríguez, DiamelisRivas, Mª. ÁngelesRojo, Marina Laura RodríguezGarcía, Patricia FernándezAlarcón, Jaime RodríguezSan Pedro de Urquiza, Borja61Ciencias Biomédicas3299 Otras Especialidades MédicasSurgical 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).John Wiley and Sons LtdUniversidad Complutense de Madrid20212021-11-1120212021-11-11journal articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://hdl.handle.net/20.500.14352/123519reponame:Docta Complutenseinstname:Universidad Complutense de Madrid (UCM)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:docta.ucm.es:20.500.14352/1235192026-06-02T12:44:21Z
dc.title.none.fl_str_mv Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
title Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
spellingShingle Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
Aleo Luján, Esther
61
Ciencias Biomédicas
3299 Otras Especialidades Médicas
title_short Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
title_full Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
title_fullStr Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
title_full_unstemmed Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
title_sort Evaluation of the Effect of Hydroxyzine on Preoperative Anxiety and Anesthetic Adequacy in Children: Double Blind Randomized Clinical Trial
dc.creator.none.fl_str_mv Aleo Luján, Esther
Picado, Amanda López
Abancens, Belén Joyanes
Soto Beauregard, María Del Carmen
Tur Salamanca, Nuria
Esteban Polonios, Carmen
Torrejón, María José
Perrino, Carlos González
Rivas Paterna, Ana Belén
Arias, Eva
Rodríguez, Diamelis
Rivas, Mª. Ángeles
Rojo, Marina Laura Rodríguez
García, Patricia Fernández
Alarcón, Jaime Rodríguez
San Pedro de Urquiza, Borja
author Aleo Luján, Esther
author_facet Aleo Luján, Esther
Picado, Amanda López
Abancens, Belén Joyanes
Soto Beauregard, María Del Carmen
Tur Salamanca, Nuria
Esteban Polonios, Carmen
Torrejón, María José
Perrino, Carlos González
Rivas Paterna, Ana Belén
Arias, Eva
Rodríguez, Diamelis
Rivas, Mª. Ángeles
Rojo, Marina Laura Rodríguez
García, Patricia Fernández
Alarcón, Jaime Rodríguez
San Pedro de Urquiza, Borja
author_role author
author2 Picado, Amanda López
Abancens, Belén Joyanes
Soto Beauregard, María Del Carmen
Tur Salamanca, Nuria
Esteban Polonios, Carmen
Torrejón, María José
Perrino, Carlos González
Rivas Paterna, Ana Belén
Arias, Eva
Rodríguez, Diamelis
Rivas, Mª. Ángeles
Rojo, Marina Laura Rodríguez
García, Patricia Fernández
Alarcón, Jaime Rodríguez
San Pedro de Urquiza, Borja
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidad Complutense de Madrid
dc.subject.none.fl_str_mv 61
Ciencias Biomédicas
3299 Otras Especialidades Médicas
topic 61
Ciencias Biomédicas
3299 Otras Especialidades Médicas
description 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).
publishDate 2021
dc.date.none.fl_str_mv 2021
2021-11-11
2021
2021-11-11
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.14352/123519
url https://hdl.handle.net/20.500.14352/123519
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv John Wiley and Sons Ltd
publisher.none.fl_str_mv John Wiley and Sons Ltd
dc.source.none.fl_str_mv reponame:Docta Complutense
instname:Universidad Complutense de Madrid (UCM)
instname_str Universidad Complutense de Madrid (UCM)
reponame_str Docta Complutense
collection Docta Complutense
repository.name.fl_str_mv
repository.mail.fl_str_mv
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