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Frontiers in Pharmacology 2020Midazolam is recommended by health guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive...
Midazolam is recommended by health guidelines for sedation and hypnosis in children. Oral solution is a suitable dosage form for children. But there is no conclusive evidence for sedative-hypnosis and antianxiety effects by midazolam oral solution in children. Relevant studies were identified through searching PubMed, Embase, Cochrane Library, CINAHL, International Pharmaceuticals, four Chinese electronic databases, and relevant lists. Two reviewers independently selected trials, assessed trial quality, and extracted the data. Eighty-nine randomized controlled trials (RCTs) comparing midazolam oral solution with placebo or blank ( = 33), dexmedetomidine ( = 15), ketamine ( = 11), different midazolam doses ( = 10), midazolam injection ( = 8), chloral hydrate ( = 7), diazepam ( = 5), NO ( = 5), triclofos ( = 4), butorphanol ( = 2), fentanyl ( = 2), hydroxyzine ( = 1), and thiopental ( = 1) were identified. Meta-analysis showed no significant difference in the success rate and duration of sedation and hypnosis between midazolam oral and injectable solution ( > 0.05). The success rate of sedation and hypnosis of midazolam was higher than that of ketamine [risk ratio (RR) = 1.32, 95% CI (1.07, 1.62), = 0%, < 0.01]. No significant difference was found in the success rate of sedation and hypnosis, mask acceptance, and parental separation between midazolam oral solution and dexmedetomidine ( > 0.05), and the result of one cohort study was consistent. The results of RCTs and a prospective cohort study showed that the incidence of adverse drug reactions (ADR) was 19.57% (189/966). Incidence of adverse reactions between dose groups of (0.25, 0.5] and (0.5, 1.0] mg/kg was similar [Pf (95% CI) = 0.10 (0.04, 0.24) and Pf (95% CI) = 0.09 (0.02, 0.39), respectively], higher than that of the dose group of (0, 0.25] mg/kg [Pf (95% CI) = 0.01 (0.00, 0.19)]. Available evidence suggests that midazolam oral solution is as good as midazolam injection and dexmedetomidine and is better than ketamine. Based on efficacy and safety results, an oral midazolam solution dose of 0.5-1 mg/kg is recommended for children.
PubMed: 32256348
DOI: 10.3389/fphar.2020.00225 -
BMC Anesthesiology Nov 2023Emergence agitation (EA) is a prevalent complication in children following general anesthesia. Several studies have assessed the relationship between melatonin or its... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Emergence agitation (EA) is a prevalent complication in children following general anesthesia. Several studies have assessed the relationship between melatonin or its analogs and the incidence of pediatric EA, yielding conflicting results. This meta-analysis aims to assess the effects of premedication with melatonin or its analogs on preventing EA in children after general anesthesia.
METHODS
PubMed, EMBASE, the Cochrane Library, ProQuest Dissertations & Theses Global, Web of Science, CNKI, Wanfang Data, clinicaltrials.gov, and WHO International Clinical Trials Registry Platform were searched until 25 November 2022. We included randomized controlled trials that assessed EA in patients less than 18 years old who underwent general anesthesia. We excluded studies that did not use a specific evaluation to assess EA.
RESULTS
Nine studies (951 participants) were included in this systematic review. Melatonin significantly reduced the incidence of EA compared with placebos (risk ratio 0.40, 95% CI 0.26 to 0.61, P < 0.01) and midazolam (risk ratio 0.48, 95% CI 0.32 to 0.73, P < 0.01). Dexmedetomidine remarkably decreased the incidence of EA compared with melatonin (risk ratio 2.04, 95% CI 1.11 to 3.73, P = 0.02).
CONCLUSIONS
Melatonin premedication significantly decreases the incidence of EA compared with placebos and midazolam. Dexmedetomidine premedication has a stronger effect than melatonin in preventing EA. Nevertheless, further studies are warranted to reinforce and validate the conclusion on the efficacy of melatonin premedication in mitigating EA in pediatric patients.
Topics: Child; Humans; Adolescent; Midazolam; Dexmedetomidine; Emergence Delirium; Melatonin; Sevoflurane; Methyl Ethers; Premedication
PubMed: 38037000
DOI: 10.1186/s12871-023-02356-x -
Neurotrauma Reports 2020Intravenous propofol, fentanyl, and midazolam are utilized commonly in critical care for metabolic suppression and anesthesia. The impact of propofol, fentanyl, and...
Intravenous propofol, fentanyl, and midazolam are utilized commonly in critical care for metabolic suppression and anesthesia. The impact of propofol, fentanyl, and midazolam on cerebrovasculature and cerebral blood flow (CBF) is unclear in traumatic brain injury (TBI) and may carry important implications, as care is shifting to focus on cerebrovascular reactivity monitoring/directed therapies. The aim of this study was to perform a scoping review of the literature on the cerebrovascular/CBF effects of propofol, fentanyl, and midazolam in human patients with moderate/severe TBI and animal models with TBI. A search of MEDLINE, BIOSIS, EMBASE, Global Health, SCOPUS, and the Cochrane Library from inception to May 2020 was performed. All articles were included pertaining to the administration of propofol, fentanyl, and midazolam, in which the impact on CBF/cerebral vasculature was recorded. We identified 14 studies: 8 that evaluated propofol, 5 that evaluated fentanyl, and 2 that evaluated midazolam. All studies suffered from significant limitations, including: small sample size, and heterogeneous design and measurement techniques. In general, there was no significant change seen in CBF/cerebrovascular response to administration of propofol, fentanyl, or midazolam during experiments where PCO and mean arterial pressure (MAP) were controlled. This review highlights the current knowledge gap surrounding the impact of commonly utilized sedative drugs in TBI care. This work supports the need for dedicated studies, both experimental and human-based, evaluating the impact of these drugs on CBF and cerebrovascular reactivity/response in TBI.
PubMed: 33251530
DOI: 10.1089/neur.2020.0040 -
AAS Open Research 2021Some patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been reported to exhibit neurological symptoms such as seizures and impaired...
Some patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been reported to exhibit neurological symptoms such as seizures and impaired consciousness. Our study reviews reported cases to assess the pharmacological approach to managing seizures in SARS-CoV-2 patients and associated outcomes. A systematic review of case reports on the incidence of seizures following coronavirus disease 2019 (COVID-19) among patients that reported use of antiepileptic drugs (AEDs) in management was performed by using the PRISMA (preferred reporting items for systematic reviews and meta-analysis) guidelines. Databases used included EMBASE, PubMed, SCOPUS, and Google Scholar. Data was presented as qualitative and descriptive data. In total, 67 articles were selected for full-text assessment, of which 18 were included in the final review. Patients had a median age of 54 years, most of whom were male. Remdisivir, dexamethasone, Laninamivir, hydroxychloroquine, azithromycin, and Lopinavir-ritonavir were common agents used in the management of COVID-19. Most patients presented with either generalized tonic-clonic seizures or status epilepticus. Most patients received levetiracetam as drug choice or as part of their regimen. Other AEDs commonly prescribed included midazolam and sodium valproate. Some patients received no antiepileptic drug therapy. Most of the patients who died had more than one comorbidity. Also, most of the patients who died received COVID-19 treatment drugs. None of the patients who received midazolam as drug choice or as part of their regimen developed recurrent seizures in contrast to patients who received levetiracetam and sodium valproate as drug choice or as part of their regimen. Interestingly, none of the patients who received no AEDs suffered recurrent seizures or died. Standard guidelines for managing seizures in COVID-19 patients may be required. A limitation of this review is that it involved the use of case reports with no controls and a small number of patients.
PubMed: 36419542
DOI: 10.12688/aasopenres.13224.2 -
Cureus Apr 2023Status epilepticus is a neurological emergency associated with high morbidity and mortality with fatal outcomes if not treated well. The goal of this study was to... (Review)
Review
Status epilepticus is a neurological emergency associated with high morbidity and mortality with fatal outcomes if not treated well. The goal of this study was to compare the intramuscular and intravenous treatment of individuals with status epilepticus. A search was performed on Scopus, PubMed, Embase, and Web of Science databases for articles published in the English language in peer-reviewed publications up to March 1, 2023. Studies were included if the treatment of status epileptics was compared either directly or indirectly between intramuscular and intravenous methods. In addition, relevant papers were manually screened for in the reference lists of the included studies. Non-duplicate articles were identified. Finally, five articles were included in the analysis, of which four were randomized controlled trials and one was a retrospective cohort study. The intramuscular midazolam group's time until the first seizure stopped was significantly shorter than the intravenous diazepam group's time (7.8 versus 11.2 minutes, respectively; p = 0.047). Moreover, the percentage of patients admitted was significantly lower in the intramuscular group than in the intravenous group (p = 0.01), but the lengths of stay in the intensive care unit and the hospital did not differ significantly between the groups. Regarding seizure recurrence, the intramuscular group had fewer incidences of recurrent seizures. Finally, there were no appreciable differences in safety outcomes between the two treatment arms. During the analysis, different outcomes reported after the use of intramuscular and intravenous treatments in managing patients with status epilepticus were categorized. This categorization led to a clear view of the efficacy and safety of intramuscular versus intravenous treatments in managing status epilepticus patients. The information at hand indicates that intramuscular therapy is just as successful as intravenous therapy in treating people with status epilepticus. The availability, adverse effect profile, logistics of administration, cost, and whether it is included in hospital formularies are some of the factors to be taken into consideration when choosing the drug administration technique.
PubMed: 37252570
DOI: 10.7759/cureus.38212 -
British Journal of Clinical Pharmacology Mar 2021Although not approved, the α-adrenoceptor agonist clonidine is considered an option for long-term sedation protocols in paediatric intensive care. We reviewed adverse... (Review)
Review
AIM
Although not approved, the α-adrenoceptor agonist clonidine is considered an option for long-term sedation protocols in paediatric intensive care. We reviewed adverse effects of clonidine occurring in this indication.
METHODS
Relevant literature was systematically identified from PubMed and Embase. We included interventional and observational studies on paediatric patients admitted to intensive care units and systemically long-term sedated with clonidine-containing regimes. In duplicates, we conducted standardised and independent full-text assessment and extraction of safety data.
RESULTS
Data from 11 studies with 909 patients were analysed. The studies were heterogeneous regarding patient characteristics (age groups, comorbidity, or comedication) and sedation regimes (dosage, route, duration, or concomitant sedatives). Just four randomised controlled trials (RCTs) and one observational study had comparison groups, using placebo or midazolam. For safety outcomes, our validity evaluation showed low risk of bias only in three studies. All studies focused on haemodynamic problems, particularly bradycardia and hypotension. Observed incidences or subsequent interventions never caused concerns. However, only two RCTs allowed meaningful comparisons with control groups. Odds ratios showed no significant difference between the groups, but small sample sizes (50 and 125 patients) must be considered; pooled analyses were not reasonable.
CONCLUSION
All evaluated studies concluded that the use of clonidine in paediatric intensive care units is safe. However, a valid characterisation of the safety profile remains challenging due to limited, biased and heterogeneous data and missing investigation of long-term effects. This evaluation demonstrates the lack of data, which prevents reliable conclusions on the safety of clonidine for long-term sedation in critically ill children. For an evidence-based use, further studies are needed.
Topics: Child; Clonidine; Critical Care; Humans; Hypnotics and Sedatives; Intensive Care Units; Midazolam; Observational Studies as Topic
PubMed: 33368604
DOI: 10.1111/bcp.14552 -
World Journal of Gastrointestinal... Aug 2020Patients with cirrhosis frequently require sedation for elective endoscopic procedures. Several sedation protocols are available, but choosing an appropriate sedative in...
BACKGROUND
Patients with cirrhosis frequently require sedation for elective endoscopic procedures. Several sedation protocols are available, but choosing an appropriate sedative in patients with cirrhosis is challenging.
AIM
To conduct a systematic review and meta-analysis to compare propofol and midazolam for sedation in patients with cirrhosis during elective endoscopic procedures in an attempt to understand the best approach.
METHODS
This systematic review and meta-analysis was conducted using the PRISMA guidelines. Electronic searches were performed using MEDLINE, EMBASE, Central Cochrane, LILACS databases. Only randomized control trials (RCTs) were included. The outcomes studied were procedure time, recovery time, discharge time, and adverse events (bradycardia, hypotension, and hypoxemia). The risk of bias assessment was performed using the Revised Cochrane Risk-of-Bias tool for randomized trials (RoB-2). Quality of evidence was evaluated by GRADEpro. The meta-analysis was performed using Review Manager.
RESULTS
The search yielded 3,576 records. Out of these, 8 RCTs with a total of 596 patients (302 in the propofol group and 294 in the midazolam group) were included for the final analysis. Procedure time was similar between midazolam and propofol groups (MD: 0.25, 95%CI: -0.64 to 1.13, = 0.59). Recovery time (MD: -8.19, 95%CI: -10.59 to -5.79, < 0.00001). and discharge time were significantly less in the propofol group (MD: -12.98, 95%CI: -18.46 to -7.50, < 0.00001). Adverse events were similar in both groups (RD: 0.02, 95%CI: 0-0.04, = 0.58). Moreover, no significant difference was found for bradycardia (RD: 0.03, 95%CI: -0.01 to 0.07, = 0.16), hypotension (RD: 0.03, 95%CI: -0.01 to 0.07, = 0.17), and hypoxemia (RD: 0.00, 95%CI: -0.04 to 0.04, = 0.93). Five studies had low risk of bias, two demonstrated some concerns, and one presented high risk. The quality of the evidence was very low for procedure time, recovery time, and adverse events; while low for discharge time.
CONCLUSION
This systematic review and meta-analysis based on RCTs show that propofol has shorter recovery and patient discharge time as compared to midazolam with a similar rate of adverse events. These results suggest that propofol should be the preferred agent for sedation in patients with cirrhosis.
PubMed: 32879659
DOI: 10.4253/wjge.v12.i8.241 -
The Cochrane Database of Systematic... Oct 2021Glutamergic system dysfunction has been implicated in the pathophysiology of bipolar depression. This is an update of the 2015 Cochrane Review for the use of glutamate... (Review)
Review
BACKGROUND
Glutamergic system dysfunction has been implicated in the pathophysiology of bipolar depression. This is an update of the 2015 Cochrane Review for the use of glutamate receptor modulators for depression in bipolar disorder.
OBJECTIVES
1. To assess the effects of ketamine and other glutamate receptor modulators in alleviating the acute symptoms of depression in people with bipolar disorder. 2. To review the acceptability of ketamine and other glutamate receptor modulators in people with bipolar disorder who are experiencing depressive symptoms.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, Embase and PsycINFO all years to July 2020. We did not apply any restrictions to date, language or publication status.
SELECTION CRITERIA
RCTs comparing ketamine or other glutamate receptor modulators with other active psychotropic drugs or saline placebo in adults with bipolar depression.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected studies for inclusion, assessed trial quality and extracted data. Primary outcomes were response rate and adverse events. Secondary outcomes included remission rate, depression severity change scores, suicidality, cognition, quality of life, and dropout rate. The GRADE framework was used to assess the certainty of the evidence.
MAIN RESULTS
Ten studies (647 participants) were included in this review (an additional five studies compared to the 2015 review). There were no additional studies added to the comparisons identified in the 2015 Cochrane review on ketamine, memantine and cytidine versus placebo. However, three new comparisons were found: ketamine versus midazolam, N-acetylcysteine versus placebo, and riluzole versus placebo. The glutamate receptor modulators studied were ketamine (three trials), memantine (two), cytidine (one), N-acetylcysteine (three), and riluzole (one). Eight of these studies were placebo-controlled and two-armed. In seven trials the glutamate receptor modulators had been used as add-on drugs to mood stabilisers. Only one trial compared ketamine with an active comparator, midazolam. The treatment period ranged from a single intravenous administration (all ketamine studies), to repeated administration for riluzole, memantine, cytidine, and N-acetylcysteine (with a follow-up of eight weeks, 8 to 12 weeks, 12 weeks, and 16 to 20 weeks, respectively). Six of the studies included sites in the USA, one in Taiwan, one in Denmark, one in Australia, and in one study the location was unclear. All participants had a primary diagnosis of bipolar disorder and were experiencing an acute bipolar depressive episode, diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders fourth edition (IV) or fourth edition text revision (IV-TR). Among all glutamate receptor modulators included in this review, only ketamine appeared to be more efficacious than placebo 24 hours after infusion for response rate (odds ratio (OR) 11.61, 95% confidence interval (CI) 1.25 to 107.74; P = 0.03; participants = 33; studies = 2; I² = 0%, low-certainty evidence). Ketamine seemed to be more effective in reducing depression rating scale scores (MD -11.81, 95% CI -20.01 to -3.61; P = 0.005; participants = 32; studies = 2; I = 0%, very low-certainty evidence). There was no evidence of ketamine's efficacy in producing remission over placebo at 24 hours (OR 5.16, 95% CI 0.51 to 52.30; P = 0.72; participants = 33; studies = 2; I = 0%, very low-certainty evidence). Evidence on response, remission or depression rating scale scores between ketamine and midazolam was uncertain at 24 hours due to very low-certainty evidence (OR 3.20, 95% CI 0.23 to 45.19). In the one trial assessing ketamine and midazolam, there were no dropouts due to adverse effects or for any reason (very low-certainty evidence). Placebo may have been more effective than N-acetylcysteine in reducing depression rating scale scores at three months, although this was based on very low-certainty evidence (MD 1.28, 95% CI 0.24 to 2.31; participants = 58; studies = 2). Very uncertain evidence found no difference in response at three months (OR 0.82, 95% CI 0.32 to 2.14; participants = 69; studies = 2; very low-certainty evidence). No data were available for remission or acceptability. Extremely limited data were available for riluzole vs placebo, finding only very-low certainty evidence of no difference in dropout rates (OR 2.00, 95% CI 0.31 to 12.84; P = 0.46; participants = 19; studies = 1; I = 0%).
AUTHORS' CONCLUSIONS
It is difficult to draw reliable conclusions from this review due to the certainty of the evidence being low to very low, and the relatively small amount of data usable for analysis in bipolar disorder, which is considerably less than the information available for unipolar depression. Nevertheless, we found uncertain evidence in favour of a single intravenous dose of ketamine (as add-on therapy to mood stabilisers) over placebo in terms of response rate up to 24 hours, however ketamine did not show any better efficacy for remission in bipolar depression. Even though ketamine has the potential to have a rapid and transient antidepressant effect, the efficacy of a single intravenous dose may be limited. We did not find conclusive evidence on adverse events with ketamine, and there was insufficient evidence to draw meaningful conclusions for the remaining glutamate receptor modulators. However, ketamine's psychotomimetic effects (such as delusions or delirium) may have compromised study blinding in some studies, and so we cannot rule out the potential bias introduced by inadequate blinding procedures. To draw more robust conclusions, further methodologically sound RCTs (with adequate blinding) are needed to explore different modes of administration of ketamine, and to study different methods of sustaining antidepressant response, such as repeated administrations.
Topics: Adult; Bipolar Disorder; Depression; Humans; Ketamine; Quality of Life; Receptors, Glutamate
PubMed: 34623633
DOI: 10.1002/14651858.CD011611.pub3 -
Frontiers in Surgery 2021A meta-analysis was performed to evaluate the effect of smartphone interventions on the anxiety of the pediatric subjects at induction on the day of surgery compared to...
A meta-analysis was performed to evaluate the effect of smartphone interventions on the anxiety of the pediatric subjects at induction on the day of surgery compared to oral midazolam or standard care as control. A systematic literature search up to June 2021 was performed and nine studies selected 785 pediatric subjects on the day of surgery at the start of the study; 390 of them were using smartphone interventions, 192 were control, and 203 were using oral midazolam. They were reporting relationships between the effects of smartphone interventions on the anxiety of the pediatric subjects at induction on the day of surgery compared to oral midazolam or control. The mean difference (MD) with its 95% CIs was calculated to assess the effect of smartphone interventions on the anxiety of the pediatric subjects at induction on the day of surgery compared to oral midazolam or control using the continuous method with a fixed or a random-effects model. Smartphone interventions in pediatric subjects were significantly related to lower anxiety at induction on the day of surgery (MD, -19.74; 95% CI, -29.87 to -9.61, < 0.001) compared to control and significantly related to lower anxiety at induction on the day of surgery (MD, -7.81; 95% CI, -14.49 to -1.14, = 0.02) compared to oral midazolam. Smartphone interventions in pediatric subjects on the day of surgery may have lower anxiety at induction compared to control and oral midazolam. Further studies are needed to confirm these findings.
PubMed: 34977139
DOI: 10.3389/fsurg.2021.759958 -
The Cochrane Database of Systematic... Aug 2021This is an updated version of a Cochrane Review published in 2017. Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography... (Review)
Review
BACKGROUND
This is an updated version of a Cochrane Review published in 2017. Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography (EEG), play an important role in the assessment of neurodevelopmental disorders. The use of an appropriate sedative agent is important to ensure the successful completion of the neurodiagnostic procedures, particularly in children, who are usually unable to remain still throughout the procedure.
OBJECTIVES
To assess the effectiveness and adverse effects of chloral hydrate as a sedative agent for non-invasive neurodiagnostic procedures in children.
SEARCH METHODS
We searched the following databases on 14 May 2020, with no language restrictions: the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 12 May 2020). CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Cochrane Epilepsy.
SELECTION CRITERIA
Randomised controlled trials that assessed chloral hydrate agent against other sedative agent(s), non-drug agent(s), or placebo.
DATA COLLECTION AND ANALYSIS
Two review authors independently evaluated studies identified by the search for their eligibility, extracted data, and assessed risk of bias. Results were expressed in terms of risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
MAIN RESULTS
We included 16 studies with a total of 2922 children. The methodological quality of the included studies was mixed. Blinding of the participants and personnel was not achieved in most of the included studies, and three of the 16 studies were at high risk of bias for selective reporting. Evaluation of the efficacy of the sedative agents was also underpowered, with all the comparisons performed in small studies. Fewer children who received oral chloral hydrate had sedation failure compared with oral promethazine (RR 0.11, 95% CI 0.01 to 0.82; 1 study; moderate-certainty evidence). More children who received oral chloral hydrate had sedation failure after one dose compared to intravenous pentobarbital (RR 4.33, 95% CI 1.35 to 13.89; 1 study; low-certainty evidence), but there was no clear difference after two doses (RR 3.00, 95% CI 0.33 to 27.46; 1 study; very low-certainty evidence). Children with oral chloral hydrate had more sedation failure compared with rectal sodium thiopental (RR 1.33, 95% CI 0.60 to 2.96; 1 study; moderate-certainty evidence) and music therapy (RR 17.00, 95% CI 2.37 to 122.14; 1 study; very low-certainty evidence). Sedation failure rates were similar between groups for comparisons with oral dexmedetomidine, oral hydroxyzine hydrochloride, oral midazolam and oral clonidine. Children who received oral chloral hydrate had a shorter time to adequate sedation compared with those who received oral dexmedetomidine (MD -3.86, 95% CI -5.12 to -2.6; 1 study), oral hydroxyzine hydrochloride (MD -7.5, 95% CI -7.85 to -7.15; 1 study), oral promethazine (MD -12.11, 95% CI -18.48 to -5.74; 1 study) (moderate-certainty evidence for three aforementioned outcomes), rectal midazolam (MD -95.70, 95% CI -114.51 to -76.89; 1 study), and oral clonidine (MD -37.48, 95% CI -55.97 to -18.99; 1 study) (low-certainty evidence for two aforementioned outcomes). However, children with oral chloral hydrate took longer to achieve adequate sedation when compared with intravenous pentobarbital (MD 19, 95% CI 16.61 to 21.39; 1 study; low-certainty evidence), intranasal midazolam (MD 12.83, 95% CI 7.22 to 18.44; 1 study; moderate-certainty evidence), and intranasal dexmedetomidine (MD 2.80, 95% CI 0.77 to 4.83; 1 study, moderate-certainty evidence). Children who received oral chloral hydrate appeared significantly less likely to complete neurodiagnostic procedure with child awakening when compared with rectal sodium thiopental (RR 0.95, 95% CI 0.83 to 1.09; 1 study; moderate-certainty evidence). Chloral hydrate was associated with a higher risk of the following adverse events: desaturation versus rectal sodium thiopental (RR 5.00, 95% 0.24 to 102.30; 1 study), unsteadiness versus intranasal dexmedetomidine (MD 10.21, 95% CI 0.58 to 178.52; 1 study), vomiting versus intranasal dexmedetomidine (MD 10.59, 95% CI 0.61 to 185.45; 1 study) (low-certainty evidence for aforementioned three outcomes), and crying during administration of sedation versus intranasal dexmedetomidine (MD 1.39, 95% CI 1.08 to 1.80; 1 study, moderate-certainty evidence). Chloral hydrate was associated with a lower risk of the following: diarrhoea compared with rectal sodium thiopental (RR 0.04, 95% CI 0.00 to 0.72; 1 study), lower mean diastolic blood pressure compared with sodium thiopental (MD 7.40, 95% CI 5.11 to 9.69; 1 study), drowsiness compared with oral clonidine (RR 0.44, 95% CI 0.30 to 0.64; 1 study), vertigo compared with oral clonidine (RR 0.15, 95% CI 0.01 to 2.79; 1 study) (moderate-certainty evidence for aforementioned four outcomes), and bradycardia compared with intranasal dexmedetomidine (MD 0.17, 95% CI 0.05 to 0.59; 1 study; high-certainty evidence). No other adverse events were significantly associated with chloral hydrate, although there was an increased risk of combined adverse events overall (RR 7.66, 95% CI 1.78 to 32.91; 1 study; low-certainty evidence).
AUTHORS' CONCLUSIONS
The certainty of evidence for the comparisons of oral chloral hydrate against several other methods of sedation was variable. Oral chloral hydrate appears to have a lower sedation failure rate when compared with oral promethazine. Sedation failure was similar between groups for other comparisons such as oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam. Oral chloral hydrate had a higher sedation failure rate when compared with intravenous pentobarbital, rectal sodium thiopental, and music therapy. Chloral hydrate appeared to be associated with higher rates of adverse events than intranasal dexmedetomidine. However, the evidence for the outcomes for oral chloral hydrate versus intravenous pentobarbital, rectal sodium thiopental, intranasal dexmedetomidine, and music therapy was mostly of low certainty, therefore the findings should be interpreted with caution. Further research should determine the effects of oral chloral hydrate on major clinical outcomes such as successful completion of procedures, requirements for an additional sedative agent, and degree of sedation measured using validated scales, which were rarely assessed in the studies included in this review. The safety profile of chloral hydrate should be studied further, especially for major adverse effects such as oxygen desaturation.
Topics: Child; Chloral Hydrate; Diagnostic Techniques, Neurological; Humans; Hydroxyzine; Hypnotics and Sedatives; Midazolam; Pentobarbital
PubMed: 34397100
DOI: 10.1002/14651858.CD011786.pub3