Effects of melatonin premedication to prevent emergence agitation after general anaesthesia in children

Mihara, Takahiro; Nakamura, Naoyuki; Ka, Koui; Oba, Mari S.; Goto, Takahisa

doi:10.1097/eja.0000000000000323

Cited by 15 publications

(27 citation statements)

References 53 publications

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“…In each of the 13 MAs, more than 1000 cases were analysed. For sleep latency, pre-operative anxiety, prevention of agitation or risk of breast cancer, ten (32%) of 31 MAs reported effects that were significant at P values less than 0.05 under the random-effects model, and seven (23%) were significant at P values less than 0.001 under the random-effects model [ 31 , 33 , 38 – 41 ]. For eight MAs (25.8%), we were unable to calculate 95% PIs.…”

Section: Resultsmentioning

confidence: 99%

Melatonin and health: an umbrella review of health outcomes and biological mechanisms of action

Posadzki

Bajpai

Kyaw

et al. 2018

BMC Med

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BackgroundOur aims were to evaluate critically the evidence from systematic reviews as well as narrative reviews of the effects of melatonin (MLT) on health and to identify the potential mechanisms of action involved.MethodsAn umbrella review of the evidence across systematic reviews and narrative reviews of endogenous and exogenous (supplementation) MLT was undertaken. The Oxman checklist for assessing the methodological quality of the included systematic reviews was utilised. The following databases were searched: MEDLINE, EMBASE, Web of Science, CENTRAL, PsycINFO and CINAHL. In addition, reference lists were screened. We included reviews of the effects of MLT on any type of health-related outcome measure.ResultsAltogether, 195 reviews met the inclusion criteria. Most were of low methodological quality (mean -4.5, standard deviation 6.7). Of those, 164 did not pool the data and were synthesised narratively (qualitatively) whereas the remaining 31 used meta-analytic techniques and were synthesised quantitatively. Seven meta-analyses were significant with P values less than 0.001 under the random-effects model. These pertained to sleep latency, pre-operative anxiety, prevention of agitation and risk of breast cancer.ConclusionsThere is an abundance of reviews evaluating the effects of exogenous and endogenous MLT on health. In general, MLT has been shown to be associated with a wide variety of health outcomes in clinically and methodologically heterogeneous populations. Many reviews stressed the need for more high-quality randomised clinical trials to reduce the existing uncertainties.Electronic supplementary materialThe online version of this article (10.1186/s12916-017-1000-8) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Melatonin and health: an umbrella review of health outcomes and biological mechanisms of action

Posadzki

Bajpai

Kyaw

et al. 2018

BMC Med

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“…The patients in the placebo group received the same amount of syrup alone. We determined the dose of ramelteon according to the previous meta-analysis regarding melatonin 9 , which showed that premedication with 0.1-0.5 mg kg −1 of melatonin may effectively prevent emergence agitation 9 . Because ramelteon is a melatonin receptor agonist with higher affinity than that of melatonin itself 10,11 , 0.1 mg kg −1 was considered adequate for the present study.…”

Section: Randomisation and Interventionmentioning

confidence: 99%

“…www.nature.com/scientificreports/ Statistical analysis. According to a previous study conducted at our hospital 23 and the previous metaanalysis regarding melatonin 9 , we assumed an emergence agitation incidence of 67% and 21% for the placebo and ramelteon groups, respectively. To enable the detection of differences, we set an alpha error of 0.05 and a statistical power of 0.80.…”

Section: Randomisation and Interventionmentioning

confidence: 99%

Preventive effect of ramelteon on emergence agitation after general anaesthesia in paediatric patients undergoing tonsillectomy: a randomised, placebo-controlled clinical trial

Komazaki

Mihara

Nakamura

et al. 2020

Sci Rep

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Purpose of this prospective, double-blind, parallel-group, placebo-controlled, randomised clinical trial was to confirm our hypothesis that ramelteon has a preventive effect on emergence agitation after general anaesthesia in children. Patients aged 18 to 119 months (ASA physical status 1 or 2), scheduled to undergo tonsillectomy under general anaesthesia, were randomly allocated to the ramelteon or placebo group. Before general anaesthesia induction, patients in the ramelteon group received 0.1 mg kg−1 of ramelteon dissolved in 5 mL of lactose-containing syrup. The patients in the placebo group received the same amount of syrup alone. The Paediatric Anaesthesia Emergence Delirium score was calculated every 5 min after awakening. The primary outcome was the incidence of emergence agitation (Paediatric Anaesthesia Emergence Delirium score ≥ 10). Paediatric Anaesthesia Emergence Delirium scores, post-operative vomiting incidence, pain scores, and adverse events were secondary outcomes. Fifty patients were enrolled. Forty-eight patients were analysed. There was no significant between-group difference in the incidence of emergence agitation (67% in both groups; risk ratio, 1.0; 95% CI 0.67–1.49; P > 0.99) or any of the secondary outcomes. Our results suggest that 0.1 mg kg−1 of ramelteon does not have a preventive effect on emergence agitation after general anaesthesia in children undergoing tonsillectomy.

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“…Although the risk of false-positive results from meta-analyses has been estimated to be as high as 35–50% [ 10 , 11 ], it can be reduced by using a Trial Sequential Analysis (TSA) [ 12 ]. Therefore, we consider TSA an essential tool for meta-analysis [ 13 ], and we used TSA to minimize the high risk of false-positive results.…”

Section: Introductionmentioning

confidence: 99%

Effects of Steroids on Quality of Recovery and Adverse Events after General Anesthesia: Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials

Mihara

Ishii

et al. 2016

PLoS ONE

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BackgroundQuality of recovery (QoR) after surgery is a relevant outcome. The early postoperative quality of recovery of a patient can be determined using the QoR-40 questionnaire. The aim of this meta-analysis and Trial Sequential Analysis was to determine if perioperative administration of glucocorticosteroids improved patients’ quality of recovery after general anesthesia and if adverse events occurred.MethodsWe searched six databases, including trial registration sites. Randomized clinical trials reporting the efficacy of glucocorticosteroids on quality of recovery evaluated using the QoR-40 after general anesthesia were eligible. The QoR-40 data were combined as the mean difference with confidence intervals using a random-effects model. The I2 statistic was used to assess heterogeneity. The quality of the trials was evaluated using the Cochrane methodology. Moreover, Trial Sequential Analysis was carried out to prevent the inflation of type 1 errors caused by multiple testing and sparse data. We also assessed adverse events.ResultsThree randomized clinical trials (totaling 301 patients) were analyzed. The results from one published and four unpublished randomized clinical trials were unavailable. Dexamethasone was investigated in all three trials, and the results suggested that it significantly improved QoR-40 at postoperative day one scores compared with placebo (mean difference [95% confidence interval]: 14.2 points [10.4 to 18.1]; P < 0.001; I2 = 0%). We could not conduct sensitivity analysis because of the absence of trials with low risk of bias. The Trial Sequential Analysis-adjusted confidence interval was -1.6 to 30.0, indicating that further trials are required. The reporting of adverse events was insufficient.ConclusionsThese findings indicate that perioperative dexamethasone administration may improve short-term (i.e., one day) quality of recovery after general anesthesia and surgery. We need more randomized clinical trials with low risk of bias assessing the effects of glucocorticosteroids on quality of life, other outcomes, and adverse events. Updated systematic reviews should then be conducted.Trial RegistrationUniversity Hospital Medical Information Network Clinical Trials Registry: UMIN000015678.

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Effects of melatonin premedication to prevent emergence agitation after general anaesthesia in children

Cited by 15 publications

References 53 publications

Melatonin and health: an umbrella review of health outcomes and biological mechanisms of action

Melatonin and health: an umbrella review of health outcomes and biological mechanisms of action

Preventive effect of ramelteon on emergence agitation after general anaesthesia in paediatric patients undergoing tonsillectomy: a randomised, placebo-controlled clinical trial

Effects of Steroids on Quality of Recovery and Adverse Events after General Anesthesia: Meta-Analysis and Trial Sequential Analysis of Randomized Clinical Trials

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