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Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial

IMPORTANCE: Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia, and they may be affected by the administration of preoperative sedatives. OBJECTIVE: To investigate the effect of intranasal dexmedetomidine or midazolam used for premedication...

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Autores principales: Shen, Fangming, Zhang, Qin, Xu, Yahui, Wang, Xinghe, Xia, Jiayi, Chen, Chao, Liu, He, Zhang, Yueying
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364121/
https://www.ncbi.nlm.nih.gov/pubmed/35943745
http://dx.doi.org/10.1001/jamanetworkopen.2022.25473
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author Shen, Fangming
Zhang, Qin
Xu, Yahui
Wang, Xinghe
Xia, Jiayi
Chen, Chao
Liu, He
Zhang, Yueying
author_facet Shen, Fangming
Zhang, Qin
Xu, Yahui
Wang, Xinghe
Xia, Jiayi
Chen, Chao
Liu, He
Zhang, Yueying
author_sort Shen, Fangming
collection PubMed
description IMPORTANCE: Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia, and they may be affected by the administration of preoperative sedatives. OBJECTIVE: To investigate the effect of intranasal dexmedetomidine or midazolam used for premedication on the occurrence of PRAEs. DESIGN, SETTING, AND PARTICIPANTS: This single-center, double-blind, randomized clinical trial was conducted among children aged 0 to 12 years undergoing elective tonsillectomy and adenoidectomy from October 2020 to June 2021 at Children’s Hospital of Xuzhou Medical University, Xuzhou, China. Data analysis was performed from June to October 2021. INTERVENTIONS: Children were randomly assigned to 3 groups: the midazolam group received intranasal midazolam (0.1 mg/kg), and the dexmedetomidine group received intranasal dexmedetomidine (2.0 μg/kg) for premedication. The normal saline group received intranasal 0.9% saline for control. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in the incidence of PRAEs among the 3 groups. The secondary outcomes were the frequency of the individual PRAEs, including the incidence of such events during the induction and recovery periods, postoperative emergence delirium, postoperative pain score, sedation success rate, and heart rate values. RESULTS: A total of 384 children (median [IQR] age, 7 [5-10] years; 227 boys [59.1%]) were enrolled and randomized; 373 data sets were available for intention-to-treat analysis (124 children in the midazolam group, 124 children in the dexmedetomidine group, and 125 children in the normal saline group). After the data were adjusted for age, sex, American Society of Anesthesiologists physical status, body mass index, obstructive sleep apnea, upper respiratory tract infection, and passive smoking, children in the midazolam group were more likely to experience PRAEs than those in the normal saline group (70 of 124 children [56.5%] vs 51 of 125 children [40.8%]; adjusted odds ratio [aOR], 1.99; 95% CI, 1.18-3.35), whereas the dexmedetomidine group had a significantly lower PRAEs incidence than the normal saline group (30 of 124 children [24.2%] vs 51 of 125 children [40.8%]; aOR, 0.45; 95% CI, 0.26-0.78). Compared with the dexmedetomidine group, the midazolam group had a higher risk of PRAEs (aOR, 4.44; 95% CI, 2.54-7.76), but no other serious clinical adverse events were observed. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, intranasal midazolam used for premedication was associated with increased incidence of PRAEs, whereas premedication with intranasal dexmedetomidine was associated with reduced incidence of PRAEs. Where clinically appropriate, anesthesiologists should consider using intranasal dexmedetomidine for sedation in children undergoing tonsillectomy and adenoidectomy. TRIAL REGISTRATION: Chinese Clinical Trial Register Identifier: ChiCTR2000038359
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spelling pubmed-93641212022-08-19 Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial Shen, Fangming Zhang, Qin Xu, Yahui Wang, Xinghe Xia, Jiayi Chen, Chao Liu, He Zhang, Yueying JAMA Netw Open Original Investigation IMPORTANCE: Perioperative respiratory adverse events (PRAEs) are the most common complication during pediatric anesthesia, and they may be affected by the administration of preoperative sedatives. OBJECTIVE: To investigate the effect of intranasal dexmedetomidine or midazolam used for premedication on the occurrence of PRAEs. DESIGN, SETTING, AND PARTICIPANTS: This single-center, double-blind, randomized clinical trial was conducted among children aged 0 to 12 years undergoing elective tonsillectomy and adenoidectomy from October 2020 to June 2021 at Children’s Hospital of Xuzhou Medical University, Xuzhou, China. Data analysis was performed from June to October 2021. INTERVENTIONS: Children were randomly assigned to 3 groups: the midazolam group received intranasal midazolam (0.1 mg/kg), and the dexmedetomidine group received intranasal dexmedetomidine (2.0 μg/kg) for premedication. The normal saline group received intranasal 0.9% saline for control. MAIN OUTCOMES AND MEASURES: The primary outcome was the difference in the incidence of PRAEs among the 3 groups. The secondary outcomes were the frequency of the individual PRAEs, including the incidence of such events during the induction and recovery periods, postoperative emergence delirium, postoperative pain score, sedation success rate, and heart rate values. RESULTS: A total of 384 children (median [IQR] age, 7 [5-10] years; 227 boys [59.1%]) were enrolled and randomized; 373 data sets were available for intention-to-treat analysis (124 children in the midazolam group, 124 children in the dexmedetomidine group, and 125 children in the normal saline group). After the data were adjusted for age, sex, American Society of Anesthesiologists physical status, body mass index, obstructive sleep apnea, upper respiratory tract infection, and passive smoking, children in the midazolam group were more likely to experience PRAEs than those in the normal saline group (70 of 124 children [56.5%] vs 51 of 125 children [40.8%]; adjusted odds ratio [aOR], 1.99; 95% CI, 1.18-3.35), whereas the dexmedetomidine group had a significantly lower PRAEs incidence than the normal saline group (30 of 124 children [24.2%] vs 51 of 125 children [40.8%]; aOR, 0.45; 95% CI, 0.26-0.78). Compared with the dexmedetomidine group, the midazolam group had a higher risk of PRAEs (aOR, 4.44; 95% CI, 2.54-7.76), but no other serious clinical adverse events were observed. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, intranasal midazolam used for premedication was associated with increased incidence of PRAEs, whereas premedication with intranasal dexmedetomidine was associated with reduced incidence of PRAEs. Where clinically appropriate, anesthesiologists should consider using intranasal dexmedetomidine for sedation in children undergoing tonsillectomy and adenoidectomy. TRIAL REGISTRATION: Chinese Clinical Trial Register Identifier: ChiCTR2000038359 American Medical Association 2022-08-09 /pmc/articles/PMC9364121/ /pubmed/35943745 http://dx.doi.org/10.1001/jamanetworkopen.2022.25473 Text en Copyright 2022 Shen F et al. JAMA Network Open. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the CC-BY License.
spellingShingle Original Investigation
Shen, Fangming
Zhang, Qin
Xu, Yahui
Wang, Xinghe
Xia, Jiayi
Chen, Chao
Liu, He
Zhang, Yueying
Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title_full Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title_fullStr Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title_full_unstemmed Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title_short Effect of Intranasal Dexmedetomidine or Midazolam for Premedication on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomy and Adenoidectomy: A Randomized Clinical Trial
title_sort effect of intranasal dexmedetomidine or midazolam for premedication on the occurrence of respiratory adverse events in children undergoing tonsillectomy and adenoidectomy: a randomized clinical trial
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9364121/
https://www.ncbi.nlm.nih.gov/pubmed/35943745
http://dx.doi.org/10.1001/jamanetworkopen.2022.25473
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