Systematic Review and Meta-analysis of Efficacy and Safety of Melatonin and Triclofos for Inducing Adequate Sedation for Sleep Electroencephalogram in Children
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SUBMITTER: Panda P
PROVIDER: S-EPMC8803531 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo conduct a systematic review of the efficacy and safety of exogenous melatonin in managing secondary sleep disorders and sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder.Data sources13 electronic databases and reference lists of relevant reviews and included studies; Associated Professional Sleep Society abstracts (1999 to 2003).Study selectionThe efficacy review included randomised controlled trials; the safety review included randomised and non-randomised controlled trials.Quality assessmentRandomised controlled trials were assessed by using the Jadad Scale and criteria by Schulz et al, and non-randomised controlled trials by the Downs and Black checklist.Data extraction and synthesisOne reviewer extracted data and another reviewer verified the data extracted. The inverse variance method was used to weight studies and the random effects model was used to analyse data.Main resultsSix randomised controlled trials with 97 participants showed no evidence that melatonin had an effect on sleep onset latency in people with secondary sleep disorders (weighted mean difference -13.2 (95% confidence interval -27.3 to 0.9) min). Nine randomised controlled trials with 427 participants showed no evidence that melatonin had an effect on sleep onset latency in people who had sleep disorders accompanying sleep restriction (-1.0 (-2.3 to 0.3) min). 17 randomised controlled trials with 651 participants showed no evidence of adverse effects of melatonin with short term use (three months or less).ConclusionsThere is no evidence that melatonin is effective in treating secondary sleep disorders or sleep disorders accompanying sleep restriction, such as jet lag and shiftwork disorder. There is evidence that melatonin is safe with short term use.
| S-EPMC1370968 | biostudies-literature
Project description:Delayed sleep-wake phase disorder (DSPD) is the most frequently occurring intrinsic circadian rhythm sleep-wake disorder, with the highest prevalence in adolescence. Melatonin is the first-choice drug treatment. However, to date melatonin (in a controlled-release formulation) is only authorised for the treatment of insomnia in children with autism or Smiths-Magenis syndrome. Concerns have been raised with respect to the safety and efficacy of melatonin for more general use in children, as melatonin has not undergone the formal safety testing required for a new drug, especially long-term safety in children. Melatonin is known to have profound effects on the reproductive systems of rodents, sheep and primates, as well as effects on the cardiovascular, immune and metabolic systems. The objective of the present article was therefore to establish the efficacy and safety of exogenous melatonin for use in children with DSPD, based on in vitro, animal model and clinical studies by reviewing the relevant literature in the Medline database using PubMed. Acute toxicity studies in rats and mice showed toxic effects only at extremely high melatonin doses (>400 mg/kg), some tens of thousands of times more than the recommended dose of 3-6 mg in a person weighing 70 kg. Longer-term administration of melatonin improved the general health and survival of ageing rats or mice. A full range of in vitro/in vivo genotoxicity tests consistently found no evidence that melatonin is genotoxic. Similarly long term administration of melatonin in rats or mice did not have carcinogenic effects, or negative effects on cardiovascular, endocrine and reproductive systems. With regard to clinical studies, in 19 randomised controlled trials comprising 841 children and adolescents with DSPD, melatonin treatment (usually of 4 weeks duration) consistently improved sleep latency by 22-60 min, without any serious adverse effects. Similarly, 17 randomised controlled trials, comprising 1374 children and adolescents, supplementing melatonin for indications other than DSPD, reported no relevant adverse effects. In addition, 4 long-term safety studies (1.0-10.8 yr) supplementing exogenous melatonin found no substantial deviation of the development of children with respect to sleep quality, puberty development and mental health scores. Finally, post-marketing data for an immediate-release melatonin formulation (Bio-melatonin), used in the UK since 2008 as an unlicensed medicine for sleep disturbance in children, recorded no adverse events to date on sales of approximately 600,000 packs, equivalent to some 35 million individual 3 mg tablet doses (MHRA yellow card adverse event recording scheme). In conclusion, evidence has been provided that melatonin is an efficacious and safe chronobiotic drug for the treatment of DSPD in children, provided that it is administered at the correct time (3-5 h before endogenous melatonin starts to rise in dim light (DLMO)), and in the correct (minimal effective) dose. As the status of circadian rhythmicity may change during long-time treatment, it is recommended to stop melatonin treatment at least once a year (preferably during the summer holidays).
| S-EPMC8041131 | biostudies-literature
Project description:ObjectivesSince a standard sedation protocol for pediatric colonoscopy (CS) has not been established, evidence on optimal sedative agents is needed. This study aimed to evaluate the efficacy and safety of thiamylal in sedation for pediatric CS compared to midazolam.MethodsChildren from 7 to 16 years of age who underwent CS under sedation with intravenous thiamylal or midazolam at our hospital between June 2010 and March 2024 were included in this retrospective observational study. The primary outcome was the efficacy (success rate of CS without mid-awakening) of the drugs. Meanwhile, the secondary outcomes were the sedation level during CS, procedure time, recovery time, and adverse events related to sedation.ResultsSixty children were included in the study. The success rate of CS without mid-awakening was significantly higher in the thiamylal group (90.6%) than in the midazolam group (64.3%; p = 0.03). The two groups had no significant differences in median sedation depth, procedure time, or recovery time. Adverse events related to sedation in thiamylal group (22%) and midazolam group (25%) were similar. No severe adverse events were reported.ConclusionsIntravenous thiamylal provides effective and safe sedation in children requiring CS, with little or no mid-awakening during the procedure.
| S-EPMC11439380 | biostudies-literature
Project description:Background: The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation. Methods: The authors searched the databases of PubMed, Embase, and Cochrane Library for studies published until January 2, 2021, that reported remimazolam sedation for endoscopic procedures. The sedative efficiency and the incidence of adverse events were assessed as outcomes. Cochrane Review Manager Software 5.3 was used to perform the statistical analyses. Results: Seven relevant studies involving a total of 1,996 patients were identified. We conducted a meta-analysis of the different controls used in the studies, that is, the placebo, midazolam, and propofol. The results demonstrated that remimazolam had a strong sedative effect, and its sedative efficiency was significantly higher than that of placebo [OR = 0.01, 95% CI: (0.00, 0.10), I 2 = 30%, p <0.00001]. The sedative efficiency of remimazolam was significantly higher than that of midazolam [OR = 0.12, 95% CI: (0.08, 0.21), I 2 = 0%, p < 0.00001] but lesser than that of propofol [OR = 12.22, 95% CI: (1.58, 94.47), I 2 = 0%, p = 0.02]. Regarding the adverse events, remimazolam is associated with a lower incidence of hypotension than placebo and midazolam. Similarly, remimazolam was associated with a lower incidence of hypotension and hypoxemia than propofol. Conclusions: Remimazolam is a safe and effective sedative for patients undergoing endoscopic procedures. The sedative efficiency of remimazolam was significantly higher than that of midazolam but slightly lower than that of propofol. However, the respiration and circulation inhibitory effects of remimazolam were weaker than those of midazolam and propofol.
| S-EPMC8350069 | biostudies-literature
Project description:ObjectiveThis meta-analysis aims to evaluate the sedative efficacy and safety of intranasal administration of dexmedetomidine (DEX) compared with oral chloral hydrate for Computed tomography (CT) or Magnetic Resonance Imaging (MRI) examination in Children.MethodsCochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), and China WanFang Databases were searched to collect randomized controlled trials (RCTs) investigating intranasal DEX (test group) vs. oral chloral hydrate (control group) in pediatric CT/MRI examinations up to December 30, 2021. The data were analyzed using Stata 15.0 software.ResultsSeven RCTs with 1,846 children were identified. The meta-analysis results showed that the success rate of sedation (RR = 1.14, 95% CI: 1.03-1.26, P = 0.011), sedation onset time [weighted mean difference (WMD) = -0.87, 95% CI: -1.42 to -0.31, P = 0.002], sedation duration (WMD = -9.05, 95% CI:-14.69 to -3.42, P = 0.002), time to awakening (WMD = -9.75, 95% CI:-17.57 to -1.94, P = 0.014), and incidence of nausea and vomiting [relative risk (RR) = 0.09, 95% CI:0.04-0.23, P < 0.001) of the test group were significantly better than those of the control group. However, no significant differences were identified in incidence of hypotension (RR = 1.18, 95% CI: 0.51-2.74) and bradycardia (RR = 1.17, 95% CI: 0.13-22.11) between the two groups.ConclusionIntranasal administration of DEX is superior to oral chloral hydrate for sedation during pediatric CT/MRI examinations and has a better safety profile.
| S-EPMC9008694 | biostudies-literature
Project description:Aim This study aimed to evaluate the effectiveness of melatonin in treating insomnia in children with autism spectrum disorder (ASD).Methods Comprehensive searches were conducted in the PubMed, EMBASE, and Web of Science databases from their inception to April 20, 2022. Data were extracted and assessed for quality by two researchers. Statistical analysis was performed using the Stata 15.0 software.Results Four studies including 238 patients were included. The results showed that compared with the control group, melatonin could shorten the sleep-onset latency (standardized mean difference [SMD] = - 1.34, 95% CI: -2.19 to -0.48), reduce the number of awakenings (SMD = -2.35, 95% CI: -4.62 to -0.08), and prolong the total sleep time (SMD = 1.42, 95% CI: 0.5-2.33) in children with ASD.Conclusion Melatonin has a certain effect on relieving sleep disturbances in children with ASD, which can shorten sleep latency, reduce the number of awakenings, and prolong total sleep time. Larger studies are required to verify this hypothesis.
| S-EPMC10166641 | biostudies-literature
Project description:We examined the sleep electroencephalogram (EEG) in 9- and 10-year-old children with (PH+) and without (PH-) a parental history of alcohol abuse/dependence to determine whether sleep disturbances associated with alcohol precede the onset of alcohol use. Participants slept on a fixed sleep schedule that ensured at least a 10-h time in bed for 1 week before an adaptation and baseline night. Data were collected in a four-bed sleep research laboratory. Thirty healthy boys and girls aged 9 or 10 years were classified as either PH+ or PH- based on DSM-IV criteria applied to structured parental interviews. All-night polysomnography was performed, sleep data were scored visually in 30-s epochs, and EEG power spectra were calculated for each epoch. All-night EEG spectra were calculated for rapid eye movement (REM) and non-REM (NREM) sleep, and cycle-by-cycle spectra were calculated for NREM sleep. The two groups did not differ on any sleep stage variable. All-night analyses revealed normalized power in the delta band and spindle range were lower in PH+ children. Within NREM sleep cycles PH+ children exhibited less normalized power in the delta band and spindle range compared with PH- children. This effect occurred in the first four cycles and was most pronounced in the first sleep cycle of the night. We found no signs of sleep disruption in sleep stages for PH+ children. Sleep EEG spectral differences, however, suggest that certain circuits responsible for 'protecting' sleep may be impaired in PH+ children, which may lead to disrupted sleep later in life.
| S-EPMC2873133 | biostudies-literature
Project description:AimTo evaluate the effectiveness of pharmacological interventions for managing non-respiratory sleep disturbances in children with neurodisabilities.MethodWe performed a systematic review and meta-analyses of randomized controlled trials (RCTs). We searched 16 databases, grey literature, and reference lists of included papers up to February 2017. Data were extracted and assessed for quality by two researchers (B.B., C.M., G.S., A.S., A.P.).ResultsThirteen trials were included, all evaluating oral melatonin. All except one were at high or unclear risk of bias. There was a statistically significant increase in diary-reported total sleep time for melatonin compared with placebo (pooled mean difference 29.6min, 95% confidence interval [CI] 6.9-52.4, p=0.01). Statistical heterogeneity was high (97%). For the single RCT with low risk of bias, the unadjusted mean difference in total sleep time was 13.2 minutes (95% CI -13.3 to 39.7) favouring melatonin, while the mean difference adjusted for baseline total sleep time was statistically significant (22.4min, 95% CI 0.5-44.3, p=0.04). Adverse event profile suggested that melatonin was well-tolerated.InterpretationThere is a paucity of evidence on managing sleep disturbances in children with neurodisabilities, and it is mostly of limited scope and poor quality. There is evidence of the benefit and safety of melatonin compared with placebo, although the extent of this benefit is unclear.What this paper addsMelatonin for the management of non-respiratory sleep disturbances in children with neurodisabilities was well tolerated with minimal adverse effects. The extent of benefit and which children might benefit most from melatonin use is uncertain. Benefit may be greatest in those with autism spectrum disorder; however, this finding should be interpreted with caution.
| S-EPMC6617775 | biostudies-literature
Project description:BackgroundTo evaluate the efficacy and safety of rectal chloral hydrate (CH) in pediatric procedural sedation.MethodsSeven electronic databases and 3 clinical trials registry platforms were searched, and the deadline was August 2022. Randomized controlled trials evaluating the efficacy and safety of rectal CH in pediatric procedural sedation were included by 2 reviewers. The extracted outcomes included the success rate of sedation, sedation latency, sedation duration, and adverse events. The Cochrane risk of bias tool was used to assess the risk of bias. The outcomes were analyzed using Review Manager 5.3 software.ResultsForty-four randomized controlled trials with 8007 children were included in the meta-analysis. The success rate of sedation in the rectal CH group was significantly higher than that in the placebo group (risk ratio [RR], 2.60 [95% confidence interval [CI], 1.74-3.89]; P < .01; RR, 1.24 [95% CI, 1.01-1.54]; P = .04), oral CH group (RR, 1.12 [95% CI, 1.09-1.14]; I2 = 36%; P < .001; number needed to treat [NNT] = 10), diazepam group (RR, 1.21 [95% CI, 1.10-1.33]; I2 = 0%; P < .001; NNT = 6), phenobarbital group (RR, 1.24 [95% CI, 1.13-1.35]; I2 = 12%; P < .001; NNT = 6), and ketamine group (RR, 1.39 [95% CI, 1.20-1.60]; I2 = 20%; P < .001; NNT = 5). There was no significant difference in the success rate of sedation between the rectal CH group and the midazolam group (RR, 0.98 [95% CI, 0.86-1.11]; I2 = 51%; P > .05). The sedation latency was significantly shorter in rectal CH group than that in the oral CH group (mean difference [MD], -6.36 [95% CI, -7.04 to -5.68]; I2 = 49%; P < .001) and the phenobarbital group (MD, -7.64 [95% CI, -9.12 to -6.16]; P < .00001). The sedation duration in the rectal CH group was significantly longer than in the oral CH group (MD, 6.43 [95% CI, 4.39-8.47]; I2 = 0%; P < .001). The overall incidence of adverse events was significantly lower with rectal CH than with oral CH (RR, 0.21 [95% CI, 0.16-0.29]; I2 = 45%; P < .001) and ketamine (RR, 0.26 [95% CI, 0.12-0.60]; I2 = 0%; P = .001). There was no significant difference in the overall incidence of adverse events with rectal CH compared with intramuscular midazolam (RR, 0.55 [95% CI, 0.23-1.28]; P = .17) and intranasal midazolam (RR, 3.00 [95% CI, 0.66-13.69]; P = .16).ConclusionThe available evidence suggests that rectal CH cloud be an effective and safe sedative agent for pediatric procedural sedation.
| S-EPMC11365616 | biostudies-literature
Project description:BackgroundPatients who undergo gastrointestinal endoscopy often require propofol-based sedation combined with analgesics. At present, the efficacy and safety of esketamine as an adjunct to propofol for sedation during endoscopic procedures in patients remains controversial. Moreover, there is no universal agreement regarding the appropriate dose of esketamine supplementation. This study aimed to assess the efficacy and safety of esketamine as an adjunct to propofol for sedation during endoscopic procedures in patients.MethodsSeven electronic databases and three clinical trial registry platforms were searched and the deadline was February 2023. Randomized controlled trials (RCTs) evaluating the efficacy of esketamine for sedation were included by two reviewers. Data from the eligible studies were combined to calculate the pooled risk ratio or standardized mean difference.ResultsEighteen studies with 1962 esketamine participants were included in the analysis. As an adjunct to propofol, the administration of esketamine reduced the recovery time compared to normal saline (NS). However, there was no significant difference between the opioids group and ketamine group. For propofol dosage, the administration of esketamine required a lower propofol dosage compared to the NS group and opioids group].For complications, the esketamine group had fewer complications compared to the NS group and opioid group in patients, but there were no significant differences between the esketamine group and ketamine group. Notably, the coadministration of esketamine was associated with a higher risk of visual disturbance compared to the NS group. In addition, we used subgroup analysis to investigate whether 0.2-0.5 mg/kg esketamine was effective and tolerable for patients.ConclusionEsketamine as an adjunct to propofol, is an appropriate effective alternative for sedation in participants undergoing gastrointestinal endoscopy. However, considering the possibility of its psychotomimetic effects, esketamine should be used with caution.
| S-EPMC10262466 | biostudies-literature