Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial.

Szczegóły
Abstrakt

Tytuł:: Intranasal dexmedetomidine versus oral midazolam premedication to prevent emergence delirium in children undergoing strabismus surgery: A randomised controlled trial.
Autorzy:: Yao Y; From the Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University (YY, JL, WC, YL, XZ) and Department of Gynaecology, Fujian Cancer Hospital, Affiliated Hospital of Fujian Medical University (YS).
Sun Y
Lin J
Chen W
Lin Y
Zheng X
Źródło:: European journal of anaesthesiology [Eur J Anaesthesiol] 2020 Dec; Vol. 37 (12), pp. 1143-1149.
Typ publikacji:: Journal Article; Randomized Controlled Trial
Język:: English
Imprint Name(s):: Publication: Cambridge : Lippincott Williams & Wilkins, 2009-
Original Publication: Oxford ; Boston : Published on behalf of the European Academy of Anaesthesiology by Blackwell Scientific, 1984-2004
MeSH Terms:: Dexmedetomidine*/adverse effects
Emergence Delirium*/diagnosis
Emergence Delirium*/epidemiology
Emergence Delirium*/prevention & control
Strabismus*/surgery
Child ; Double-Blind Method ; Humans ; Hypnotics and Sedatives/adverse effects ; Midazolam/adverse effects ; Premedication ; Prospective Studies
References:: Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol 2014; 27:309–315.
Driscoll JN, Bender BM, Archilla CA, et al. Comparing incidence of emergence delirium between sevoflurane and desflurane in children following routine otolaryngology procedures. Minerva Anestesiol 2017; 83:383–391.
Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth 2017; 118:335–343.
Moore AD, Anghelescu DL. Emergence delirium in paediatric anaesthesia. Paediatr Drugs 2017; 19:11–20.
Cho EJ, Yoon SZ, Cho JE, et al. Comparison of the effects of 0.03 and 0.05 mg/kg midazolam with placebo on prevention of emergence agitation in children having strabismus surgery. Anesthesiology 2014; 120:1354–1361.
Breschan C, Platzer M, Jost R, et al. Midazolam does not reduce emergence delirium after sevoflurane anaesthesia in children. Paediatr Anaesth 2007; 17:347–352.
Dahmani S, Brasher C, Stany I, et al. Premedication with clonidine is superior to benzodiazepines. A meta-analysis of published studies. Acta Anaesthesiol Scand 2010; 54:397–402.
Plambech MZ, Afshari A. Dexmedetomidine in the pediatric population: a review. Minerva Anestesiol 2015; 81:320–332.
Jun JH, Kim KN, Kim JY, et al. The effects of intranasal dexmedetomidine premedication in children: a systematic review and meta-analysis. Can J Anaesth 2017; 64:947–961.
Makkar JK, Bhatia N, Bala I, et al. A comparison of single dose dexmedetomidine with propofol for the prevention of emergence delirium after desflurane anaesthesia in children. Anaesthesia 2016; 71:50–57.
Hauber JA, Davis PJ, Bendel LP, et al. Dexmedetomidine as a rapid bolus for treatment and prophylactic prevention of emergence agitation in anesthetized children. Anesth Analg 2015; 121:1308–1315.
FitzSimons J, Bonanno LS, Pierce S, et al. Effectiveness of preoperative intranasal dexmedetomidine, compared with oral midazolam, for the prevention of emergence delirium in the paediatric patient undergoing general anaesthesia: a systematic review. JBI Database Syst Rev Implement Rep 2017; 15:1934–1951.
Juszczak E, Altman DG, Hopewell S, et al. Reporting of Multi-Arm Parallel-Group Randomized Trials: extension of the CONSORT 2010 statement. JAMA 2019; 321:1610–1620.
Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anaesthesia emergence delirium scale. Anesthesiology 2004; 100:1138–1145.
Koner O, Ture H, Mercan A, et al. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol 2011; 28:640–645.
Crellin D, Sullivan TP, Babl FE, et al. Analysis of the validation of existing behavioural pain and distress scales for use in the procedural setting. Paediatr Anaesth 2007; 17:720–733.
Aldrete JA. The postanaesthesia recovery score revisited. J Clin Anesth 1995; 7:89–91.
Aouad MT, Yazbeck-Karam VG, Nasr VG, et al. A single dose of propofol at the end of surgery for the prevention of emergence agitation in children undergoing strabismus surgery during sevoflurane anaesthesia. Anesthesiology 2007; 107:733–738.
Uusalo P, Guillaume S, Siren S, et al. Pharmacokinetics and sedative effects of intranasal dexmedetomidine in ambulatory paediatric patients. Anesth Analg 2019; 130:949–957.
Bergendahl HT, Lonnqvist PA, Eksborg S, et al. Clonidine vs midazolam as premedication in children undergoing adenotonsillectomy: a prospective, randomised, controlled clinical trial. Acta Anaesthesiol Scand 2004; 48:1292–1300.
Li A, Yuen VM, Goulay-Dufay S, et al. Pharmacokinetic and pharmacodynamic study of intranasal and intravenous dexmedetomidine. Br J Anaesth 2018; 120:960–968.
Vlajkovic GP, Sindjelic RP. Emergence delirium in children: many questions, few answers. Anesth Analg 2007; 104:84–91.
Somaini M, Engelhardt T, Fumagalli R, et al. Emergence delirium or pain after anaesthesia-how to distinguish between the two in young children: a retrospective analysis of observational studies. Br J Anaesth 2016; 116:377–383.
Yuen VM, Hui TW, Irwin MG, et al. A randomised comparison of two intranasal dexmedetomidine doses for premedication in children. Anaesthesia 2012; 67:1210–1216.
Cao Q, Lin Y, Xie Z, et al. Comparison of sedation by intranasal dexmedetomidine and oral chloral hydrate for pediatric ophthalmic examination. Paediatr Anaesth 2017; 27:629–636.
Molecular Sequence:: ClinicalTrials.gov NCT01895023
Substance Nomenclature:: 0 (Hypnotics and Sedatives)
67VB76HONO (Dexmedetomidine)
R60L0SM5BC (Midazolam)
Entry Date(s):: Date Created: 20200925 Date Completed: 20210427 Latest Revision: 20210427
Update Code:: 20240105
DOI:: 10.1097/EJA.0000000000001270
PMID:: 32976205
: Czasopismo naukowe

Background: Dexmedetomidine is being used increasingly as a premedicant in the paediatric population. However, the effectiveness of pre-operative intranasal dexmedetomidine premedication, compared with oral midazolam, for emergence delirium is not well characterised.
Objective: To identify the effectiveness of pre-operative intranasal dexmedetomidine for emergence delirium in the paediatric patient population following general anaesthesia.
Design: A prospective, randomised, double-blind, parallel-group, placebo-controlled trial.
Setting: Single university teaching hospital, from September 2013 to August 2014.
Patients: One hundred and fifty-six patients undergoing anaesthesia for strabismus surgery were included in the study.
Intervention: Patients were randomised in a 1 : 1 : 1 ratio to receive premedication with intranasal dexmedetomidine 2 μg kg (the dexmedetomidine group), oral midazolam 0.5 mg kg (the midazolam group), or 0.9% saline (the placebo group).
Main Outcome Measures: The primary outcome was the incidence of emergence delirium assessed by the Paediatric Anaesthesia Emergence Delirium scale. Secondary outcomes included the quality of the inhalational induction, emergence time, postoperative pain intensity, length of stay in the postanaesthesia care unit, the incidence of postoperative nausea or vomiting (PONV) and parents' satisfaction.
Results: The incidence of emergence delirium was lower in patients given dexmedetomidine compared with that in patients given midazolam (11.5 versus 44%, relative risk = 0.262, 95% confidence interval 0.116 to 0.592) or 0.9% saline (11.5 versus 49%, relative risk = 0.235, 95% confidence interval 0.105 to 0.525). Likewise, the incidence of PONV was lower in the dexmedetomidine group (3.8%) than that in the midazolam (22%; P = 0.006) or placebo (29.4%; P < 0.001) groups. However, there was no difference among the groups concerning postoperative pain scores and length of postanaesthesia care unit stay.
Conclusion: In paediatric patients undergoing strabismus surgery intranasal dexmedetomidine 2 μg kg premedication decreases the incidence of emergence delirium and PONV, and improves parents' satisfaction compared with oral midazolam.
Trial Registration: ClinicalTrials.gov (identifier: NCT01895023).

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