Systematic Review and Meta-analysis of Efficacy and Safety of Melatonin and Triclofos for Inducing Adequate Sedation for Sleep Electroencephalogram in Children
Ontology highlight
ABSTRACT:
SUBMITTER: Panda P
PROVIDER: S-EPMC8803531 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
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: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: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:BackgroundThe majority of children who undergo gastrointestinal (GI) endoscopy require anesthesia or procedural sedation for comfort, cooperation, and procedure efficiency. The safety profile of propofol is not well established in children but has been studied in the literature.ObjectiveThe aim of this study is to evaluate and compare the safety of propofol-only sedation for GI endoscopy procedures to other anesthetic regimes in the pediatric population.MethodsA search was conducted in the MEDLINE, Embase, and Cochrane Library databases. Randomized clinical trials and prospective cohorts were included in the study.ResultsNo significant difference was noted in total complications between the two cohorts with a pooled OR of 1.31 (95% CI: 0.57-3.04, chi2?=?0.053, I2?=?54.31%). The pooled rate of complications in the studies was 23.4% for those receiving propofol only and 18.2% for those receiving other anesthetic regimens. Sensitivity analysis was performed removing a study with a very different control comparison compared to the rest of the studies included. Once excluded, there was minimal heterogeneity in the remaining studies and a significant difference in overall complications was detected, with more complications seen in the propofol-only group compared to the other anesthetic groups (OR 1.87, 95% CI 1.09-3.20).ConclusionSignificantly higher incidence of cardiorespiratory complications was noted in the propofol-only versus other anesthetic regimens in pediatric patients undergoing GI endoscopy in this meta-analysis. However, the overall quality of the evidence is very low.How to apply this knowledge for routine clinical practiceClinicians providing sedation to a pediatric population for GI endoscopy should consider there may be increased risks when using a propofol-only regimen, but further study is needed.
| S-EPMC6126059 | biostudies-literature
Project description:BACKGROUND:Sedation with etomidate or propofol alone during gastroscopy has many side effects. A systematic review and meta-analysis were conducted to evaluate the safety and efficacy of the combined use of propofol and etomidate for sedation during gastroscopy. METHODS:PubMed, Embase, Medline (via Ovid SP), Cochrane library databases, CINAHL (via EBSCO), China Biology Medicine disc (CBMdisc), Wanfang, VIP, and China National Knowledge Infrastructure (CNKI) databases were systematically searched. We included randomized controlled trials (RCTs) comparing the combined use of propofol and etomidate vs etomidate or propofol alone for sedation during gastroscopy. Data were pooled using the random-effects models or fixed-effect model based on heterogeneity. RESULTS:Fifteen studies with 2973 participants were included in the analysis. Compared to propofol alone, the combined use of propofol and etomidate possibly increased recovery time (SMD?=?0.14, 95% CI?=?0.04-0.24; P?=?.005), and the risk for myoclonus (OR?=?3.07, 95% CI?=?1.73-5.44; P?<?.001), injection pain, and nausea and vomiting. Furthermore, compared to propofol alone, the combination of propofol and etomidate produced an apparent beneficial effect for mean arterial pressure (MAP) after anesthesia (SMD?=?1.32, 95% CI?=?0.38-2.26; P?=?.006), SPO2 after anesthesia (SMD?=?0.99, 95% CI?=?0.43-1.55; P?<?.001), apnea or hypoxemia (OR?=?0.16, 95% CI?=?0.08-0.33; P?<?.001), injection pain, and body movement. Further, compared to etomidate alone, the combination of propofol and etomidate reduced the risk for myoclonus (OR?=?0.15, 95% CI?=?0.11-0.22; P?<?.001), body movement, and nausea and vomiting. CONCLUSION:The combination of propofol and etomidate might increase recovery time vs that associated with propofol, but it had fewer side effects on circulation and respiration in patients undergoing gastroscopy. The combined use of propofol and etomidate can improve and produce an apparent beneficial effect on the adverse effects of propofol or etomidate alone, and it was safer and more effective than propofol or etomidate alone.
| S-EPMC6531275 | biostudies-literature
Project description:Background: Remimazolam is a new ultrashort-acting benzodiazepine. Remimazolam has been approved for procedural sedation by the US Food and Drug Administration in 2020. However, prior trials and the participants they enrolled were limited. Aim: In this meta-analysis, we investigated the effectiveness and adverse events (AEs) of remimazolam during procedural sedation. Materials and Methods: The study protocol was registered (doi: 10.37766/inplasy2020.8.0043), and six databases were searched. We performed meta-analysis, trial sequential analysis (TSA), and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology for judging the certainty of evidence (CoE). Results: A total of five randomized controlled trials with 1,248 participants were included. Compared with the use of midazolam, the utilization of remimazolam resulted in an increase in procedure success rate [odds ratio (OR) = 9.01, 95% confidence interval (CI): 2.35-34.57], a reduction in the application of rescue medication (OR = 13.58, 95% CI: 3.46-53.28), a decrease in time to recovery [minutes, weighted mean difference (WMD) = -5.70, 95% CI: -8.68 to -2.72], and a better cognitive recovery of Hopkins Verbal Learning Test-Revised (WMD = 5.22, 95% CI: 2.88-7.55). No difference was found in completion of procedure (OR = 1.68, 95% CI: 0.72-3.90) with inconclusive in TSA. Despite no difference of total AEs (OR = 0.60, 95% CI: 0.24-1.50), more detailed analysis of AEs remained inconclusive in TSA. The GRADE assessment demonstrated low to very low CoE. Conclusion: Our analysis suggested that remimazolam may be a better choice for procedural sedation than midazolam. Nevertheless, further studies are warranted to conclusively establish its safety.
| S-EPMC8353129 | biostudies-literature
Project description:Objective: A recent double-blind randomized placebo-controlled study demonstrated 3-month efficacy and safety of a novel pediatric-appropriate prolonged-release melatonin (PedPRM) for insomnia in children and adolescents with autism spectrum disorder (ASD) and neurogenetic disorders (NGD) with/without attention-deficit/hyperactivity disorder comorbidity. Long-term efficacy and safety of PedPRM treatment was studied. Methods: A prospective, open-label efficacy and safety follow-up of nightly 2, 5, or 10?mg PedPRM in subjects who completed the 13-week double-blind trial (51 PedPRM; 44 placebo). Measures included caregiver-reported Sleep and Nap Diary, Composite Sleep Disturbance Index (CSDI), caregiver's Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale, and quality of life (WHO-5 Well-Being Index). Results: Ninety-five subjects (74.7% males; mean [standard deviation] age, 9 [4.24]; range, 2-17.5 years) received PedPRM (2/5?mg) according to the double-blind phase dose, for 39 weeks with optional dose adjustment (2, 5, or 10?mg/day) after the first 13 weeks. After 52 weeks of continuous treatment (PedPRM-randomized group) subjects slept (mean [SE]) 62.08 (21.5) minutes longer (p?=?0.007); fell asleep 48.6 (10.2) minutes faster (p?<?0.001); had 89.1 (25.5) minutes longer uninterrupted sleep episodes (p?=?0.001); 0.41 (0.12) less nightly awakenings (>50% decrease; p?=?0.001); and better sleep quality (p?<?0.001) compared with baseline. The placebo-randomized group also improved with PedPRM. Altogether, by the end of 39-week follow-up, regardless of randomization assignment, 55/72 (76%) of completers achieved overall improvement of ?1 hour in total sleep time (TST), sleep latency or both, over baseline, with no evidence of decreased efficacy. In parallel, CSDI child sleep disturbance and caregivers' satisfaction of their child's sleep patterns (p?<?0.001 for both), PSQI global (p?<?0.001), and WHO-5 (p?=?0.001) improved in statistically significant and clinically relevant manner (n?=?72) compared with baseline. PedPRM was generally safe; most frequent treatment-related adverse events were fatigue (5.3%) and mood swings (3.2% of patients). Conclusion: PedPRM, an easily swallowed formulation shown to be efficacious versus placebo, is an efficacious and safe option for long-term treatment (up to 52 weeks reported here) of children with ASD and NGD who suffer from insomnia and subsequently improves caregivers' quality of life.
| S-EPMC6306655 | biostudies-literature
Project description:Study objectivesTo investigate the efficacy of melatonin compared to placebo in improving sleep parameters in patients with primary sleep disorders.DesignPubMed was searched for randomized, placebo-controlled trials examining the effects of melatonin for the treatment of primary sleep disorders. Primary outcomes examined were improvement in sleep latency, sleep quality and total sleep time. Meta-regression was performed to examine the influence of dose and duration of melatonin on reported efficacy.ParticipantsAdults and children diagnosed with primary sleep disorders.InterventionsMelatonin compared to placebo.ResultsNineteen studies involving 1683 subjects were included in this meta-analysis. Melatonin demonstrated significant efficacy in reducing sleep latency (weighted mean difference (WMD) = 7.06 minutes [95% CI 4.37 to 9.75], Z = 5.15, p<0.001) and increasing total sleep time (WMD = 8.25 minutes [95% CI 1.74 to 14.75], Z = 2.48, p = 0.013). Trials with longer duration and using higher doses of melatonin demonstrated greater effects on decreasing sleep latency and increasing total sleep time. Overall sleep quality was significantly improved in subjects taking melatonin (standardized mean difference = 0.22 [95% CI: 0.12 to 0.32], Z = 4.52, p<0.001) compared to placebo. No significant effects of trial duration and melatonin dose were observed on sleep quality.ConclusionThis meta-analysis demonstrates that melatonin decreases sleep onset latency, increases total sleep time and improves overall sleep quality. The effects of melatonin on sleep are modest but do not appear to dissipate with continued melatonin use. Although the absolute benefit of melatonin compared to placebo is smaller than other pharmacological treatments for insomnia, melatonin may have a role in the treatment of insomnia given its relatively benign side-effect profile compared to these agents.
| S-EPMC3656905 | biostudies-literature