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Medicine Dec 2017Volatile sedation in the intensive care unit (ICU) may reduce the number of adverse events and improve patient outcomes compared with intravenous (IV) sedation. We... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Volatile sedation in the intensive care unit (ICU) may reduce the number of adverse events and improve patient outcomes compared with intravenous (IV) sedation. We performed a systematic review and meta-analysis comparing the effects of volatile and IV sedation in adult ICU patients.
METHODS
We searched the PubMed, Embase, Cochrane Central Register, and Web of Science databases for all randomized trials comparing volatile sedation using an anesthetic-conserving device (ACD) with IV sedation in terms of awakening and extubation times, lengths of ICU and hospital stay, and pharmacologic end-organ effects.
RESULTS
Thirteen trials with a total of 1027 patients were included. Volatile sedation (sevoflurane or isoflurane) administered through an ACD shortened the awakening time [mean difference (MD), -80.0 minutes; 95% confidence intervals (95% CIs), -134.5 to -25.6; P = .004] and extubation time (MD, -196.0 minutes; 95% CIs, -305.2 to -86.8; P < .001) compared with IV sedation (midazolam or propofol). No differences in the lengths of ICU and hospital stay were noted between the 2 groups. In the analysis of cardiac effects of sedation from 5 studies, patients who received volatile sedation showed lower serum troponin levels 6 hours after ICU admission than patients who received IV sedation (P < .05). The effect size of troponin was largest between 12 and 24 hours after ICU admission (MD, -0.27 μg/L; 95% CIs, -0.44 to -0.09; P = .003).
CONCLUSION
Compared with IV sedation, volatile sedation administered through an ACD in the ICU shortened the awakening and extubation times. Considering the difference in serum troponin levels between both arms, volatile anesthetics might have a myocardial protective effect after cardiac surgery even at a subanesthetic dose. Because the included studies used small sample sizes with high heterogeneity, further large, high-quality prospective clinical trials are needed to confirm our findings.
Topics: Airway Extubation; Anesthetics, Inhalation; Humans; Intensive Care Units; Isoflurane; Length of Stay; Methyl Ethers; Randomized Controlled Trials as Topic; Sevoflurane
PubMed: 29245269
DOI: 10.1097/MD.0000000000008976 -
International Journal of Clinical... 2022To assess and compare the effectiveness of midazolam vs midazolam and ketamine combination in the management of young uncooperative pediatric patients.
Comparative Evaluation of Ease of Dental Treatment and Clinical Efficiency of Midazolam vs Midazolam and Ketamine Combination for Sedation in Young Uncooperative Pediatric Patients: A Systematic Review.
AIM
To assess and compare the effectiveness of midazolam vs midazolam and ketamine combination in the management of young uncooperative pediatric patients.
MATERIALS AND METHODS
The research question was developed by using population, intervention, comparison, outcome, and study design framework. The literature search was performed using three electronic databases: PubMed, Scopus, and EBSCOhost. The risk of bias of the studies was independently appraised using the Cochrane Handbook for Systematic Reviews of Interventions.
RESULTS
Out of 98 preliminary records, five studies were selected for analysis. Three hundred forty-six uncooperative children were randomized through the five randomized controlled trials (RCTs), with a mean age of 5.8 years. Midazolam with ketamine was the most successful combination for delivering rapid and sufficient analgosedation in uncooperative children. The clinical efficiency of midazolam and ketamine combination had an overall success rate of 84% when compared to ketamine and midazolam alone. 50% of children in the midazolam and ketamine group demonstrated calm behavior, compared to 37% in the midazolam group. 44% of the children experienced modest intra and/or postoperative adverse effects that did not necessitate any special treatment.
CONCLUSION
Midazolam and ketamine combination is more efficient than midazolam alone with respect to ease of treatment and clinical efficiency.
HOW TO CITE THIS ARTICLE
Rathi GV, Padawe D, Takate V, Comparative Evaluation of Ease of Dental Treatment and Clinical Efficiency of Midazolam vs Midazolam and Ketamine Combination for Sedation in Young Uncooperative Pediatric Patients: A Systematic Review. Int J Clin Pediatr Dent 2022;15(6):680-686.
PubMed: 36866134
DOI: 10.5005/jp-journals-10005-2456 -
The Cochrane Database of Systematic... May 2017Although routine administration of pharmacologic sedation or analgesia during mechanical ventilation in preterm neonates is not recommended, its use in clinical practice... (Review)
Review
BACKGROUND
Although routine administration of pharmacologic sedation or analgesia during mechanical ventilation in preterm neonates is not recommended, its use in clinical practice remains common. Alpha-2 agonists, mainly clonidine and dexmedetomidine, are used as adjunctive (or alternative) sedative agents alongside opioids and benzodiazepines. Clonidine has not been systematically assessed for use in neonatal sedation during ventilation.
OBJECTIVES
To assess whether clonidine administered to term and preterm newborn infants receiving mechanical ventilation reduces morbidity and mortality rates. To compare the intervention versus placebo, no treatment, and dexmedetomidine; and to assess the safety of clonidine infusion for potential harms.To perform subgroup analyses according to gestational age; birth weight; administration method (infusion or bolus therapy); dose, duration, and route of clonidine administration; and pharmacologic sedation as a co-intervention.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group to search the Cochrane Central Register of Controlled Trials (CENTRAL; 2016, Issue 12) in the Cochrane Library, MEDLINE via PubMed (1966 to January 10, 2017), Embase (1980 to January 10, 2017), and the Cumulative Index to Nursing and Allied Health Literature (CINAHL; 1982 to January 10, 2017). We also searched clinical trials databases, conference proceedings, and the reference lists of retrieved articles for randomized controlled trials and quasi-randomized trials.
SELECTION CRITERIA
We searched for randomized controlled trials, quasi-randomized controlled trials, and cluster trials comparing clonidine versus placebo, no treatment, or dexmedetomidine administered to term and preterm newborns receiving mechanical ventilation via an endotracheal tube.
DATA COLLECTION AND ANALYSIS
For the included trial, two review authors independently extracted data (e.g. number of participants, birth weight, gestational age, all-cause death during initial hospitalization, duration of respiratory support, sedation scale, duration of hospital stay) and assessed risk of bias (e.g. adequacy of randomization, blinding, completeness of follow-up). This review considered primary outcomes of all-cause neonatal death, all-cause death during initial hospitalization, and duration of mechanical ventilation in days.
MAIN RESULTS
One trial, which included 112 infants, met the inclusion criteria for this review. Term newborn infants on mechanical ventilation with the need for continuous analgesia and sedation with fentanyl and midazolam were eligible for enrollment during the first 96 hours of ventilation. Study authors administered clonidine 1 μg/kg/h or placebo on day 4 after intubation.We found no differences between the two groups in all-cause death during hospitalization (risk ratio [RR] 0.69, 95% confidence interval [CI] 0.12 to 3.98). The quality of the evidence supporting these findings is low owing to imprecision of the estimates (one study; few events). The median (interquartile range) duration of mechanical ventilation was 7.1 days (5.7 to 9.1 days) in the clonidine group and 5.8 days (4.9 to 7.9 days) in the placebo group, respectively (P = 0.070). Among secondary outcomes, we found no differences in terms of duration of stay in the intensive care unit. Sedation scale values (COMFORT) and analgesia scores (Hartwig) during the first 72 hours of infusion of study medication were lower in the clonidine group than in the placebo group.
AUTHORS' CONCLUSIONS
At present, evidence is insufficient to show the efficacy and safety of clonidine for sedation and analgesia in term and preterm newborn infants receiving mechanical ventilation.
Topics: Cause of Death; Clonidine; Dexmedetomidine; Hospital Mortality; Humans; Hypnotics and Sedatives; Infant, Newborn; Intensive Care Units, Neonatal; Length of Stay; Randomized Controlled Trials as Topic; Respiration, Artificial
PubMed: 28488361
DOI: 10.1002/14651858.CD012468.pub2 -
Cureus Jun 2022We aim to discuss the efficacy and adverse effects of using ketamine in agitated patients in the emergency department (ED) compared with the combination therapy of... (Review)
Review
A Comparative Analysis Between Ketamine Versus Combination of Midazolam and Haloperidol for Rapid Safe Control of Agitated Patients in Emergency Department: A Systematic Review.
We aim to discuss the efficacy and adverse effects of using ketamine in agitated patients in the emergency department (ED) compared with the combination therapy of haloperidol with benzodiazepine. This systematic review followed Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) guidelines. An electronic search from PubMed/Medline, Cochrane library, and Google Scholar was conducted from their inception to 30 April 2022. We included agitated patients in ED who were given infusion with ketamine only. Our comparative group was patients infused with combined therapy of haloperidol and benzodiazepine. We did not include letters, case reports, abstracts, conference papers, appraisals, reviews, and studies where full text was unavailable. We did not put any language restrictions. Three studies were selected in our manuscript (one cohort and two randomized controlled trials). All three studies showed that ketamine was used to achieve sedation in less time than the other group. However, two studies reported significantly more adverse effects in ketamine-infused groups. We concluded that ketamine use is superior when its primary focus is to sedate the patient as quickly as possible, but it carries some side effects that should be considered. However, we still need more studies assessing the efficacy of ketamine in agitated patients presenting in the ED.
PubMed: 35891834
DOI: 10.7759/cureus.26162 -
Cureus Mar 2022Remimazolam is made by combining midazolam and remifentanil as an alternative to conventional sedatives. To evaluate the efficacy of remimazolam for sedation in... (Review)
Review
Efficacy of Remimazolam for Procedural Sedation in American Society of Anesthesiologists (ASA) I to IV Patients Undergoing Colonoscopy: A Systematic Review and Meta-Analysis.
Remimazolam is made by combining midazolam and remifentanil as an alternative to conventional sedatives. To evaluate the efficacy of remimazolam for sedation in patients undergoing colonoscopy, we conducted a systematic review and meta-analysis of the available randomized controlled trials (RCTs) comparing remimazolam and midazolam. A search was conducted using PubMed, Cochrane Library, and clinicaltrial.gov from inception till December 26, 2021, for RCTs that investigated the efficacy of remimazolam during the above-mentioned procedure. There was no restriction of language. A quality assessment was performed using the Cochrane Risk-of-Bias tool. The data were pooled, and a meta-analysis was completed. The systemic review was conducted in accordance with the Preferred Reporting Items for Systemic Reviews and Meta-Analysis (PRISMA) guideline statement. Three randomized controlled trials involving 539 patients were included in the meta-analysis. Compared with midazolam during colonoscopy, remimazolam results in reduced need for top-up doses (RR= 3.45, 95% CI=1.07 to 11.14; P=0.04, I=84%). The need for rescue medication was reduced with remimazolam as compared to midazolam (RR=2.42, 95%CI=1.04 to 5.61; P=0.04, I=96%). There was no significant difference observed between the two drugs on completion of colonoscopy and the overall procedural sedation, but the sensitivity analysis favored remimazolam over midazolam for procedural sedation (RR=4.08, 95%CI=2.35 to 7.09; P<0.00001, I=39%). This analysis demonstrates the advantages of remimazolam over other agents and sets a platform for relevant future studies.
PubMed: 35399486
DOI: 10.7759/cureus.22881 -
The Cochrane Database of Systematic... Dec 2016People experiencing acute psychotic illnesses, especially those associated with agitated or violent behaviour, may require urgent pharmacological tranquillisation or... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People experiencing acute psychotic illnesses, especially those associated with agitated or violent behaviour, may require urgent pharmacological tranquillisation or sedation. Droperidol, a butyrophenone antipsychotic, has been used for this purpose in several countries.
OBJECTIVES
To estimate the effects of droperidol, including its cost-effectiveness, when compared to placebo, other 'standard' or 'non-standard' treatments, or other forms of management of psychotic illness, in controlling acutely disturbed behaviour and reducing psychotic symptoms in people with schizophrenia-like illnesses.
SEARCH METHODS
We updated previous searches by searching the Cochrane Schizophrenia Group Register (18 December 2015). We searched references of all identified studies for further trial citations and contacted authors of trials. We supplemented these electronic searches by handsearching reference lists and contacting both the pharmaceutical industry and relevant authors.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) with useable data that compared droperidol to any other treatment for people acutely ill with suspected acute psychotic illnesses, including schizophrenia, schizoaffective disorder, mixed affective disorders, the manic phase of bipolar disorder or a brief psychotic episode.
DATA COLLECTION AND ANALYSIS
For included studies, we assessed quality, risk of bias and extracted data. We excluded data when more than 50% of participants were lost to follow-up. For binary outcomes, we calculated standard estimates of risk ratio (RR) and the corresponding 95% confidence intervals (CI). We created a 'Summary of findings' table using GRADE.
MAIN RESULTS
We identified four relevant trials from the update search (previous version of this review included only two trials). When droperidol was compared with placebo, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 227, RR 1.18, 95% CI 1.05 to 1.31, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for the droperidol group (1 RCT, N = 227, RR 0.55, 95% CI 0.36 to 0.85, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 227, RR 0.34, 95% CI 0.01 to 8.31, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 227, RR 0.62, 95% CI 0.15 to 2.52, low-quality evidence) than placebo. For 'being ready for discharge', there was no clear difference between groups (1 RCT, N = 227, RR 1.16, 95% CI 0.90 to 1.48, high-quality evidence). There were no data for mental state and costs.Similarly, when droperidol was compared to haloperidol, for the outcome of tranquillisation or asleep by 30 minutes we found evidence of a clear difference (1 RCT, N = 228, RR 1.01, 95% CI 0.93 to 1.09, high-quality evidence). There was a clear demonstration of reduced risk of needing additional medication after 60 minutes for participants in the droperidol group (2 RCTs, N = 255, RR 0.37, 95% CI 0.16 to 0.90, high-quality evidence). There was no evidence that droperidol caused more cardiovascular hypotension (1 RCT, N = 228, RR 2.80, 95% CI 0.30 to 26.49,moderate-quality evidence) and cardiovascular hypotension/desaturation (1 RCT, N = 228, RR 2.80, 95% CI 0.12 to 67.98, low-quality evidence) than haloperidol. There was no suggestion that use of droperidol was unsafe. For mental state, there was no evidence of clear difference between the efficacy of droperidol compared to haloperidol (Scale for Quantification of Psychotic Symptom Severity, 1 RCT, N = 40, mean difference (MD) 0.11, 95% CI -0.07 to 0.29, low-quality evidence). There were no data for service use and costs.Whereas, when droperidol was compared with midazolam, for the outcome of tranquillisation or asleep by 30 minutes we found droperidol to be less acutely tranquillising than midazolam (1 RCT, N = 153, RR 0.96, 95% CI 0.72 to 1.28, high-quality evidence). As regards the 'need for additional medication by 60 minutes after initial adequate sedation, we found an effect (1 RCT, N = 153, RR 0.54, 95% CI 0.24 to 1.20, moderate-quality evidence). In terms of adverse effects, we found no statistically significant differences between the two drugs for either airway obstruction (1 RCT, N = 153, RR 0.13, 95% CI 0.01 to 2.55, low-quality evidence) or respiratory hypoxia (1 RCT, N = 153, RR 0.70, 95% CI 0.16 to 3.03, moderate-quality evidence) - but use of midazolam did result in three people (out of around 70) needing some sort of 'airway management' with no such events in the droperidol group. There were no data for mental state, service use and costs.Furthermore, when droperidol was compared to olanzapine, for the outcome of tranquillisation or asleep by any time point, we found no clear differences between the older drug (droperidol) and olanzapine (e.g. at 30 minutes: 1 RCT, N = 221, RR 1.02, 95% CI 0.94 to 1.11, high-quality evidence). There was a suggestion that participants allocated droperidol needed less additional medication after 60 minutes than people given the olanzapine (1 RCT, N = 221, RR 0.56, 95% CI 0.36 to 0.87, high-quality evidence). There was no evidence that droperidol caused more cardiovascular arrhythmia (1 RCT, N = 221, RR 0.32, 95% CI 0.01 to 7.88, moderate-quality evidence) and respiratory airway obstruction (1 RCT, N = 221, RR 0.97, 95% CI 0.20 to 4.72, low-quality evidence) than olanzapine. For 'being ready for discharge', there was no difference between groups (1 RCT, N = 221, RR 1.06, 95% CI 0.83 to 1.34, high-quality evidence). There were no data for mental state and costs.
AUTHORS' CONCLUSIONS
Previously, the use of droperidol was justified based on experience rather than evidence from well-conducted and reported randomised trials. However, this update found high-quality evidence with minimal risk of bias to support the use of droperidol for acute psychosis. Also, we found no evidence to suggest that droperidol should not be a treatment option for people acutely ill and disturbed because of serious mental illnesses.
Topics: Acute Disease; Aggression; Antipsychotic Agents; Benzodiazepines; Droperidol; Haloperidol; Humans; Midazolam; Olanzapine; Psychomotor Agitation; Psychotic Disorders; Randomized Controlled Trials as Topic
PubMed: 27976370
DOI: 10.1002/14651858.CD002830.pub3 -
The Cochrane Database of Systematic... Apr 2015Anxiety in relation to surgery is a well-known problem. Melatonin offers an atoxic alternative to benzodiazepines in ameliorating this condition in the pre- and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Anxiety in relation to surgery is a well-known problem. Melatonin offers an atoxic alternative to benzodiazepines in ameliorating this condition in the pre- and postoperative period.
OBJECTIVES
To assess the effect of melatonin on pre- and postoperative anxiety in adults when comparing melatonin with placebo or when comparing melatonin with benzodiazepines.
SEARCH METHODS
The following databases were searched on 19 April 2013: CENTRAL, MEDLINE, EMBASE, CINAHL and Web of Science. For ongoing trials and protocols we searched clinicaltrials.gov, Current Controlled Trials and the World Health Organization (WHO) International Clinical Trials Registry Platform. We reran the search in October 2014. We will deal with any studies of interest when we update the review.
SELECTION CRITERIA
Randomized, placebo-controlled or standard treatment-controlled, or both, studies that evaluated the effect of preoperatively administered melatonin on preoperative or postoperative anxiety. We included adult patients of both genders (15 to 90 years of age) undergoing any kind of surgical procedure in which it was necessary to use general, regional or topical anaesthesia.
DATA COLLECTION AND ANALYSIS
Data were extracted independently by two review authors. Data extracted included information about study design, country of origin, number of participants and demographic details, type of surgery, type of anaesthesia, intervention and dosing regimen, preoperative anxiety outcome measures and postoperative anxiety outcome measures.
MAIN RESULTS
This systematic review identified 12 randomized controlled trials (RCTs) including 774 patients that assessed melatonin for treating preoperative anxiety, postoperative anxiety or both. Four of the 12 studies compared melatonin, placebo and midazolam, whereas the remaining eight studies compared melatonin and placebo only.The quality of the evidence for our primary outcome (melatonin versus placebo for preoperative anxiety) was high. More than half of the included studies had a low risk of selection bias and at least 75% of the included studies had a low risk of attrition, performance and detection bias. Most of the included studies had an unclear risk of reporting bias.Eight out the 10 studies that assessed the effect of melatonin on preoperative anxiety using a visual analogue scale (VAS) (ranging from 0 to 100 mm, higher scores indicate greater anxiety) showed a reduction compared to placebo. The reported estimate of effect (relative effect -13.36, 95% confidence interval (CI) -16.13 to -10.58; high quality evidence) was based on a meta-analysis of seven studies. Two studies did not show any difference between melatonin and placebo. Two studies comparing melatonin with midazolam using a VAS found no evidence of a difference in preoperative anxiety between the two groups (relative effect -1.18, 95% CI -2.59 to 0.23; low quality evidence).Eight studies assessed the effect of melatonin on postoperative anxiety. Four of these studies measuring postoperative anxiety 90 minutes postoperatively using a VAS did not find any evidence of a difference between melatonin and placebo (relative effect -3.71, 95% CI -9.26 to 1.84). Conversely, two studies showed a reduction of postoperative anxiety measured six hours after surgery using the State-Trait Anxiety Inventory (STAI) when comparing melatonin with placebo (relative effect -5.31, 95% CI -8.78 to -1.84; moderate quality evidence). Two studies comparing melatonin with midazolam using a VAS did not find any evidence of a difference between the two groups in postoperative anxiety (relative effect -2.02, 95% CI -5.82 to 1.78).
AUTHORS' CONCLUSIONS
When compared to placebo, melatonin given as premedication (tablets or sublingually) can reduce preoperative anxiety in adults (measured 50 to 100 minutes after administration). Melatonin may be equally as effective as standard treatment with midazolam in reducing preoperative anxiety in adults (measured 50 to 100 minutes after administration). The effect of melatonin on postoperative anxiety (measured 90 minutes and 6 hours after surgery) in adults is mixed but suggests an overall attenuation of the effect compared to preoperatively.
Topics: Adult; Anti-Anxiety Agents; Anxiety; Clonidine; Drug Administration Schedule; Humans; Melatonin; Midazolam; Postoperative Care; Preoperative Care; Publication Bias; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 25856551
DOI: 10.1002/14651858.CD009861.pub2 -
Frontiers in Pharmacology 2023The sedative role of dexmedetomidine (DEX) in gastrointestinal endoscopic procedures is unclear. We performed this systematic review and meta-analysis to assess the...
Efficacy and safety of sedation with dexmedetomidine in adults undergoing gastrointestinal endoscopic procedures: systematic review and meta-analysis of randomized controlled trials.
The sedative role of dexmedetomidine (DEX) in gastrointestinal endoscopic procedures is unclear. We performed this systematic review and meta-analysis to assess the efficacy and safety of sedation with DEX during gastrointestinal endoscopic procedures with a view to providing evidence-based references for clinical decision-making. The PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases were searched for randomized controlled trials (RCTs) that compared DEX with different sedatives comparators (such as propofol, midazolam, and ketamine) for sedation in a variety of adult gastrointestinal endoscopic procedures from inception to 1 July 2022. Standardized mean difference (SMD) and weighted mean difference (WMD) with 95% confidence interval (CI) or pooled risk ratios (RR) with 95% CI were used for continuous outcomes or dichotomous outcomes, respectively, and a random-effect model was selected regardless of the significance of the heterogeneity. Forty studies with 2,955 patients were assessed, of which 1,333 patients were in the DEX group and 1,622 patients were in the control (without DEX) group. The results suggested that the primary outcomes of sedation level of DEX are comparable to other sedatives, with similar RSS score and patient satisfaction level, and better in some clinical outcomes, with a reduced risk of body movements or gagging (RR: 0.60; 95% CI: 0.37 to 0.97; = 0.04; I = 68%), and a reduced additional requirement for other sedatives, and increased endoscopist satisfaction level (SMD: 0.41; 95% CI: 0.05 to 0.77; = 0.03; I = 86%). In terms of secondary outcomes of adverse events, DEX may benefit patients in some clinical outcomes, with a reduced risk of hypoxia (RR:0.34; 95% CI: 0.20 to 0.55; < 0.0001; I = 52%) and cough (RR: 0.25; 95% CI: 0.12 to 0.54; = 0.0004; I = 0%), no significant difference in the risk of hypotension, while an increased risk of bradycardia (RR: 3.08; 95% CI: 2.12 to 4.48; < 0.00001; I = 6%). This meta-analysis indicates that DEX is a safe and effective sedative agent for gastrointestinal endoscopy because of its benefits for patients in some clinical outcomes. Remarkably, DEX is comparable to midazolam and propofol in terms of sedation level. In conclusion, DEX provides an additional option in sedation for gastrointestinal endoscopic procedures. https://www.crd.york.ac.uk/PROSPERO/#searchadvanced.
PubMed: 38034988
DOI: 10.3389/fphar.2023.1241714 -
The Cochrane Database of Systematic... Nov 2017Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography (EEG), play an important role in the assessment of neurodevelopmental... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
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 used the standard search strategy of the Cochrane Epilepsy Group. We searched MEDLINE (OVID SP) (1950 to July 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library, Issue 7, 2017), Embase (1980 to July 2017), and the Cochrane Epilepsy Group Specialized Register (via CENTRAL) using a combination of keywords and MeSH headings.
SELECTION CRITERIA
We included randomised controlled trials that assessed chloral hydrate agent against other sedative agent(s), non-drug agent(s), or placebo for children undergoing non-invasive neurodiagnostic procedures.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the studies for their eligibility, extracted data, and assessed risk of bias. Results were expressed in terms of risk ratio (RR) for dichotomous data, mean difference (MD) for continuous data, with 95% confidence intervals (CIs).
MAIN RESULTS
We included 13 studies with a total of 2390 children. The studies were all conducted in hospitals that provided neurodiagnostic services. Most studies assessed the proportion of sedation failure during the neurodiagnostic procedure, time for adequate sedation, and potential adverse effects associated with the sedative agent.The methodological quality of the included studies was mixed, as reflected by a wide variation in their 'Risk of bias' profiles. Blinding of the participants and personnel was not achieved in most of the included studies, and three of the 13 studies had high risk of bias for selective reporting. Evaluation of the efficacy of the sedative agents was also underpowered, with all the comparisons performed in single small studies.Children who received oral chloral hydrate had lower sedation failure when compared with oral promethazine (RR 0.11, 95% CI 0.01 to 0.82; 1 study, moderate-quality evidence). Children who received oral chloral hydrate had a higher risk of sedation failure after one dose compared to those who received intravenous pentobarbital (RR 4.33, 95% CI 1.35 to 13.89; 1 study, low-quality evidence), but after two doses there was no evidence of a significant difference between the two groups (RR 3.00, 95% CI 0.33 to 27.46; 1 study, very low-quality evidence). Children who received oral chloral hydrate appeared to have more sedation failure when compared with music therapy, but the quality of evidence was very low for this outcome (RR 17.00, 95% CI 2.37 to 122.14; 1 study). Sedation failure rates were similar between oral chloral hydrate, oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam.Children who received oral chloral hydrate had a shorter time to achieve adequate sedation when compared with those who received oral dexmedetomidine (MD -3.86, 95% CI -5.12 to -2.6; 1 study, moderate-quality evidence), oral hydroxyzine hydrochloride (MD -7.5, 95% CI -7.85 to -7.15; 1 study, moderate-quality evidence), oral promethazine (MD -12.11, 95% CI -18.48 to -5.74; 1 study, moderate-quality evidence), and rectal midazolam (MD -95.70, 95% CI -114.51 to -76.89; 1 study). 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-quality evidence) and intranasal midazolam (MD 12.83, 95% CI 7.22 to 18.44; 1 study, moderate-quality evidence).No data were available to assess the proportion of children with successful completion of neurodiagnostic procedure without interruption by the child awakening. Most trials did not assess adequate sedation as measured by specific validated scales, except in the comparison of chloral hydrate versus intranasal midazolam and oral promethazine.Compared to dexmedetomidine, chloral hydrate was associated with a higher risk of nausea and vomiting (RR 12.04 95% CI 1.58 to 91.96). No other adverse events were significantly associated with chloral hydrate (including behavioural change, oxygen desaturation) although there was an increased risk of adverse events overall (RR 7.66, 95% CI 1.78 to 32.91; 1 study, low-quality evidence).
AUTHORS' CONCLUSIONS
The quality of evidence for the comparisons of oral chloral hydrate against several other methods of sedation was very variable. Oral chloral hydrate appears to have a lower sedation failure rate when compared with oral promethazine for children undergoing paediatric neurodiagnostic procedures. The sedation failure was similar for other comparisons such as oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam. When compared with intravenous pentobarbital and music therapy, oral chloral hydrate had a higher sedation failure rate. However, it must be noted that the evidence for the outcomes for the comparisons of oral chloral hydrate against intravenous pentobarbital and music therapy was of very low to low quality, therefore the corresponding 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 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 the risk of major adverse effects such as bradycardia, hypotension, and oxygen desaturation.
Topics: Administration, Oral; Adolescent; Child; Child, Preschool; Chloral Hydrate; Dexmedetomidine; Diagnostic Techniques, Neurological; Electroencephalography; Humans; Hydroxyzine; Hypnotics and Sedatives; Infant; Melatonin; Midazolam; Music Therapy; Neuroimaging; Pentobarbital; Promethazine; Randomized Controlled Trials as Topic; Treatment Failure
PubMed: 29099542
DOI: 10.1002/14651858.CD011786.pub2 -
Annals of Palliative Medicine Aug 2021In order to increase the sample size and improve the test efficiency from a statistical perspective, we conducted a combined analysis of multiple results from similar... (Meta-Analysis)
Meta-Analysis
BACKGROUND
In order to increase the sample size and improve the test efficiency from a statistical perspective, we conducted a combined analysis of multiple results from similar studies. In this study, we conducted a meta-analysis to investigate the sedative effect of dexmedetomidine on patients after cardiac surgery, so as to provide theoretical basis and help for clinical treatment of cardiac diseases.
METHODS
The Boolean logic search method was employed to search online databases for publications, with "dexmedetomidine", "cardiac surgery", "competitive antagonist", and "analgesic sedation" used as keywords. In addition, the literature was screened for comparative studies on the use of midazolam and propofol as controls. The Newcastle-Ottawa Scale (NOS) of Cochrane Collaborative Network was used to evaluate the pathological control studies in Meta-analysis, and the star rating system (out of 9 stars) was used to measure the results from the subjects, cases and groups. Finally, a meta-analysis was performed with Review Manager software (Cochrane).
RESULTS
Thirteen references containing mostly low-risk biases (medium-high quality) were included in this study. The meta-analysis showed no statistically obvious heterogeneity in the mechanical ventilation time (MVT) between patients in the control group (group A) or patients in the experimental group (group B) (Chi2=74.71; I2=92%; P<0.00001), showing no statistical significance (Z=1.57; P=0.12). Heterogeneity was found as a complication in both groups (Chi2=14.82; I2=60%; P=0.02), but fewer complications were observed in group B (Z=2.06, P=0.04). The sedative effect displayed by patients from the 2 groups during the induction of anesthesia was statistically heterogeneous (Chi2=6.45; I2=38%; P=0.17), but the sedative effect in group B was shown to be greater (Z=3.31, P=0.0009).
CONCLUSIONS
Dexmedetomidine can significantly reduce the mechanical ventilation time and the incidence of complications in patients after cardiac surgery, and has a high safety and good sedative effect on patients.
Topics: Cardiac Surgical Procedures; Dexmedetomidine; Humans; Hypnotics and Sedatives; Midazolam; Propofol
PubMed: 34488382
DOI: 10.21037/apm-21-1850