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      Ketamine Enhances Intranasal Dexmedetomidine-Induced Sedation in Children: A Randomized, Double-Blind Trial

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          Abstract

          Purpose

          To compare the efficacy of intranasal dexmedetomidine and dexmedetomidine-ketamine premedication in preschool children undergoing tonsillectomy.

          Patients and Methods

          We enrolled 66 children with American Society of Anesthesiologists physical status I or II, aged 3–7 years undergoing tonsillectomy. Patients were randomly allocated to receive intranasal premedication with either dexmedetomidine 2 μg kg −1 (Group D) or dexmedetomidine 2 μg kg −1 and ketamine 2 mg kg −1 (Group DK). The primary outcome was the sedation level assessed by the Modified Observer’s Assessment of Alertness/Sedation Scale (MOAA/S) 30 min after intervention. The minimal clinically relevant difference in the MOAA/S score was 0.5. Secondary outcomes included sedation onset time, parental separation anxiety, acceptance of mask induction, emergence time, emergence delirium, postoperative pain intensity, length of stay in the post-anesthesia care unit (PACU), and adverse effects.

          Results

          At 30 min after premedication, the MOAA/S score was lower in Group DK than in Group D patients (median: 1.0, interquartile range [IQR]: 1.0–2.0 vs median: 3.0, IQR: 2.0–3.0; P<0.001), with a median difference of 1.0 (95% confidence interval [CI]: 1.0–2.0, P<0.001). Patients in Group DK showed considerably faster onset of sedation (15 min, 95% CI: 14.2–15.8 min) than Group D (24 min, 95% CI: 23.2–24.8 min), with a median difference of 8.0 min (95% CI: 7.0–9.0 min, P<0.001). Both parental separation and facemask acceptance scores were lower in Group DK than in Group D patients ( P=0.012 and P=0.001, respectively). There was no significant difference in emergence time, incidence of emergence delirium, postoperative pain scores, and length of stay in the PACU between the two groups.

          Conclusion

          Intranasal premedication with a combination of dexmedetomidine and ketamine produced better sedation for pediatric tonsillectomy than dexmedetomidine alone.

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          Most cited references 21

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          Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations.

          Despite lack of paediatric labelling, contributions to the literature on paediatric applications of dexmedetomidine have increased over recent years. Dexmedetomidine possesses many properties that are advantageous for a sedative and anaesthetic; it has been reported to provide sedation that parallels natural sleep, anxiolysis, analgesia, sympatholysis, and an anaesthetic-sparing effect with minimal respiratory depression. In addition, there is increasing evidence supporting its organ-protective effects against ischaemic and hypoxic injury. These favourable physiological effects combined with a limited adverse effect profile make dexmedetomidine an attractive adjunct to anaesthesia (general and regional) for a variety of procedures in paediatric operating rooms. A comprehensive understanding of the pharmacological, pharmacokinetic, and pharmacodynamic effects of dexmedetomidine is critical to maximize its safe, efficacious, and efficient paediatric perioperative applications. This review focuses on the current paediatric perioperative and periprocedural applications of dexmedetomidine and its limitations, with a consideration for the future.
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            Intranasal dexmedetomidine vs midazolam for premedication in children undergoing complete dental rehabilitation: a double-blinded randomized controlled trial.

            This prospective, randomized, double-blind study was designed to evaluate the use of intranasally administered dexmedetomidine vs intranasal midazolam as a premedication in children undergoing complete dental rehabilitation. Seventy-two children of American Society of Anesthesiology classification (ASA) physical status (I & II), aged 3-6 years, were randomly assigned to one of two equal groups. Group M received intranasal midazolam (0.2 mg·kg(-1)), and group D received intranasal dexmedetomidine (1 μg·kg(-1)). The patients' sedation status, mask acceptance, and hemodynamic parameters were recorded by an observer until anesthesia induction. Recovery conditions, postoperative pain, and postoperative agitation were also recorded. The median onset of sedation was significantly shorter in group M 15 (10-25) min than in group D 25 (20-40) min (P = 0.001). Compared with the children in group M, those in group D were significantly more sedated when they were separated from their parents (77.8% vs 44.4%, respectively) (P = 0.002). Satisfactory compliance with mask application was 58.3% in group M vs 80.6% in group D (P = 0.035). The incidences of postoperative agitation and shivering were significantly lower in Group D compared with group M. Thirteen children (36.1%) in group M, showed signs of nasal irritation with teary eyes, and none of these signs was seen in the children in group D (P = 0.000). There were no incidences of bradycardia, hypotension, in either of the groups during study observation. Intranasal dexmedetomidine (1 μg·kg(-1)) is an effective and safe alternative for premedication in children; it resulted in superior sedation in comparison to 0.2 mg·kg(-1) intranasal midazolam. However, it has relatively prolonged onset of action. © 2013 John Wiley & Sons Ltd.
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              CONSORT 2010 statement: extension checklist for reporting within person randomised trials

              Evidence shows that the quality of reporting of randomised controlled trials (RCTs) is not optimal. The lack of transparent reporting impedes readers from judging the reliability and validity of trial findings and researchers from extracting information for systematic reviews and results in research waste. The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of RCTs. Within person trials are used for conditions that can affect two or more body sites, and are a useful and efficient tool because the comparisons between interventions are within people. Such trials are most commonly conducted in ophthalmology, dentistry, and dermatology. The reporting of within person trials has, however, been variable and incomplete, hindering their use in clinical decision making and by future researchers. This document presents the CONSORT extension to within person trials. It aims to facilitate the reporting of these trials. It extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Examples of good reporting and evidence based rationale for CONSORT within person checklist items are provided.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                dddt
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                26 August 2020
                2020
                : 14
                : 3559-3565
                Affiliations
                [1 ]Department of Anesthesiology, People’s Hospital Affiliated to Fujian University of Traditional Chinese Medicine , Fuzhou, Fujian, People’s Republic of China
                [2 ]Department of Anesthesiology, Shengli Clinical Medical College of Fujian Medical University , Fuzhou, Fujian, People’s Republic of China
                Author notes
                Correspondence: Yanhua Guo Tel +86-591-88217841 Email guoyanhua19@126.com
                Article
                269765
                10.2147/DDDT.S269765
                7457813
                © 2020 Qian et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 4, Tables: 6, References: 23, Pages: 7
                Categories
                Clinical Trial Report

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