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Frontiers in Medicine 2021The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation. The authors...
The aim of this systematic review and meta-analysis was to investigate the efficacy and safety of remimazolam in clinical endoscopic procedure sedation. 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. 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), = 30%, <0.00001]. The sedative efficiency of remimazolam was significantly higher than that of midazolam [OR = 0.12, 95% CI: (0.08, 0.21), = 0%, < 0.00001] but lesser than that of propofol [OR = 12.22, 95% CI: (1.58, 94.47), = 0%, = 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. 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.
PubMed: 34381792
DOI: 10.3389/fmed.2021.655042 -
Academic Emergency Medicine : Official... Jan 2008To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the... (Comparative Study)
Comparative Study Review
OBJECTIVES
To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the emergency care setting.
METHODS
The authors conducted a systematic review of randomized controlled trials (RCTs) and observational studies reporting the use of either midazolam and/or propofol for adult PS in the emergency department (ED). A systematic search strategy was developed and applied to six bibliographic reference databases. Three emergency medicine journals, the Canadian Adverse Drug Reaction Newsletter, and conference proceedings were hand-searched. Retrieved articles were reviewed and data were abstracted using standardized data collection. Trial quality was assessed using the Jadad score. The outcomes assessed were the proportion of patients with AEs and the pooled mean difference in the proportion of patients with successful PS.
RESULTS
Of 229 articles identified, 28 met the inclusion criteria for the analysis of AEs. Only one major AE to PS was found, resulting in no statistically significant difference in the proportion of major AEs between agents. Four studies were RCTs that met the inclusion criteria for the analysis of clinical effectiveness. Two trials met criteria for good quality. The RCTs enrolled between 32 and 86 patients, and the most common indications for PS were orthopedic reductions and cardioversions. There was a nonsignificant difference in the proportion of patients with successful PS in favor of propofol (effect difference 2.9%, 95% confidence interval (CI) = -6.5 to 15.2).
CONCLUSIONS
The authors found no significant difference in the safety profile and the proportion of successful PS between midazolam and propofol for adults in the ED.
Topics: Adult; Conscious Sedation; Emergency Medical Services; Humans; Hypnotics and Sedatives; Midazolam; Outcome and Process Assessment, Health Care; Propofol; Treatment Outcome
PubMed: 18211306
DOI: 10.1111/j.1553-2712.2007.00022.x -
Archives of Disease in Childhood Jan 2015To determine the extent of inter-individual variation in clearance of midazolam in children and establish which factors are responsible for this variation. (Review)
Review
OBJECTIVES
To determine the extent of inter-individual variation in clearance of midazolam in children and establish which factors are responsible for this variation.
METHODS
A systematic literature review was performed to identify papers describing the clearance of midazolam in children. The following databases were searched: Medline, Embase, International Pharmaceutical Abstracts, CINAHL and Cochrane Library. From the papers, the range in plasma clearance and the coefficient of variation (CV) in plasma clearance were determined.
RESULTS
25 articles were identified. Only 13 studies gave the full range of clearance values for individual patients. The CV was greater in critically ill patients (18%-170%) than non-critically ill patients (13%-54%). Inter-individual variation was a major problem in all age groups of critically ill patients. The CV was 72%-106% in preterm neonates, 18%-73% in term neonates, 31%-130% in infants, 21%-170% in children and 47%-150% in adolescents. The mean clearance was higher in children (1.1-16.7 mL/min/kg) than in neonates (0.78-2.5 mL/min/kg).
CONCLUSIONS
Large inter-individual variation was seen in midazolam clearance values in critically ill neonates, infants, children and adolescents.
Topics: Adolescent; Child; Critical Illness; Humans; Hypnotics and Sedatives; Infant; Infant, Newborn; Metabolic Clearance Rate; Midazolam
PubMed: 25281734
DOI: 10.1136/archdischild-2013-305720 -
Journal of Orthopaedic Surgery and... Nov 2017Midazolam has some potential in pain control of patients undergoing knee arthroscopy. However, the results remain controversial. We conduct a systematic review and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Midazolam has some potential in pain control of patients undergoing knee arthroscopy. However, the results remain controversial. We conduct a systematic review and meta-analysis to explore the effect of midazolam on pain control after knee arthroscopy.
METHODS
PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases are systematically searched. Randomized controlled trials (RCTs) assessing the effect of midazolam on pain management after knee arthroscopy are included. Two investigators have independently searched articles, extracted the data, and assessed the quality of the included studies. This meta-analysis is performed using the random-effect model.
RESULTS
Six RCTs are included in this meta-analysis. Compared with control intervention after knee arthroscopy, midazolam intervention can significantly reduce the pain scores (standard mean difference (Std. MD) = - 3.70; 95% confidence interval (CI) = - 6.81 to - 0.60; P = 0.02), the number of patients requiring analgesics (risk ratio (RR) = 0.66; 95% CI = 0.49 to 0.88; P = 0.005), and analgesic consumption (Std. MD = -1.62; 95% CI = - 3.04 to - 0.19; P = 0.03), as well as increase the time to first analgesic requirement (Std. MD = 1.58; 95% CI = 0.17 to 2.99; P = 0.03). In addition, midazolam intervention results in no increase in adverse events following knee arthroscopy (RR = 0.74; 95% CI = 0.18 to 2.98; P = 0.67).
CONCLUSIONS
Midazolam intervention is revealed to substantially reduce the pain scores, the number of patients requiring analgesics, and analgesic consumption, as well as improve the time to first analgesic requirement after knee arthroscopy.
Topics: Anesthetics, Intravenous; Arthroscopy; Humans; Knee Joint; Midazolam; Pain Management; Pain, Postoperative
PubMed: 29162135
DOI: 10.1186/s13018-017-0682-0 -
Medicine Sep 2018Propofol and midazolam are widely used for the sedation of bronchoscopy. This systematic review and meta-analysis is conducted to compare the efficacy of propofol and... (Comparative Study)
Comparative Study Meta-Analysis Review
BACKGROUND
Propofol and midazolam are widely used for the sedation of bronchoscopy. This systematic review and meta-analysis is conducted to compare the efficacy of propofol and midazolam for bronchoscopy.
METHODS
The databases including PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases are systematically searched for collecting the randomized controlled trials (RCTs) regarding the efficacy of propofol and midazolam for bronchoscopy.
RESULTS
This meta-analysis has included 4 RCTs. Compared with midazolam intervention in patients undergoing bronchoscopy, propofol intervention is associated with remarkably reduced recovery time [standard mean difference (SMD) = -0.74; 95% confidence interval (95% CI) = -1.04 to -0.45; P < .00001], but demonstrates no significant impact on operation time (SMD = -0.01; 95% CI = -0.16 to 0.13; P = .87), induction time (SMD = -0.58; 95% CI = -1.19 to 0.03; P = .06), lowest oxyhemoglobin saturation (SpO2, SMD = 0.24; 95% CI = -0.09 to 0.58; P = .15), SpO2 <90% [risk ratio (RR) = 1.02; 95% CI = 0.82-1.25; P = .88), and major arrhythmias (RR = 0.56; 95% CI = 0.26-1.19; P = .13).
CONCLUSION
Propofol sedation is able to reduce recovery time and shows similar safety compared with midazolam sedation during bronchoscopy.
Topics: Anesthetics, Intravenous; Bronchoscopy; Humans; Hypnotics and Sedatives; Midazolam; Pain, Procedural; Propofol; Randomized Controlled Trials as Topic
PubMed: 30200147
DOI: 10.1097/MD.0000000000012229 -
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 -
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 -
The Cochrane Database of Systematic... May 2016Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Midazolam is used for sedation before diagnostic and therapeutic medical procedures. It is an imidazole benzodiazepine that has depressant effects on the central nervous system (CNS) with rapid onset of action and few adverse effects. The drug can be administered by several routes including oral, intravenous, intranasal and intramuscular.
OBJECTIVES
To determine the evidence on the effectiveness of midazolam for sedation when administered before a procedure (diagnostic or therapeutic).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL to January 2016), MEDLINE in Ovid (1966 to January 2016) and Ovid EMBASE (1980 to January 2016). We imposed no language restrictions.
SELECTION CRITERIA
Randomized controlled trials in which midazolam, administered to participants of any age, by any route, at any dose or any time before any procedure (apart from dental procedures), was compared with placebo or other medications including sedatives and analgesics.
DATA COLLECTION AND ANALYSIS
Two authors extracted data and assessed risk of bias for each included study. We performed a separate analysis for each different drug comparison.
MAIN RESULTS
We included 30 trials (2319 participants) of midazolam for gastrointestinal endoscopy (16 trials), bronchoscopy (3), diagnostic imaging (5), cardioversion (1), minor plastic surgery (1), lumbar puncture (1), suturing (2) and Kirschner wire removal (1). Comparisons were: intravenous diazepam (14), placebo (5) etomidate (1) fentanyl (1), flunitrazepam (1) and propofol (1); oral chloral hydrate (4), diazepam (2), diazepam and clonidine (1); ketamine (1) and placebo (3); and intranasal placebo (2). There was a high risk of bias due to inadequate reporting about randomization (75% of trials). Effect estimates were imprecise due to small sample sizes. None of the trials reported on allergic or anaphylactoid reactions. Intravenous midazolam versus diazepam (14 trials; 1069 participants)There was no difference in anxiety (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.39 to 1.62; 175 participants; 2 trials) or discomfort/pain (RR 0.60, 95% CI 0.24 to 1.49; 415 participants; 5 trials; I² = 67%). Midazolam produced greater anterograde amnesia (RR 0.45; 95% CI 0.30 to 0.66; 587 participants; 9 trials; low-quality evidence). Intravenous midazolam versus placebo (5 trials; 493 participants)One trial reported that fewer participants who received midazolam were anxious (3/47 versus 15/35; low-quality evidence). There was no difference in discomfort/pain identified in a further trial (3/85 in midazolam group; 4/82 in placebo group; P = 0.876; very low-quality evidence). Oral midazolam versus chloral hydrate (4 trials; 268 participants)Midazolam increased the risk of incomplete procedures (RR 4.01; 95% CI 1.92 to 8.40; moderate-quality evidence). Oral midazolam versus placebo (3 trials; 176 participants)Midazolam reduced pain (midazolam mean 2.56 (standard deviation (SD) 0.49); placebo mean 4.62 (SD 1.49); P < 0.005) and anxiety (midazolam mean 1.52 (SD 0.3); placebo mean 3.97 (SD 0.44); P < 0.0001) in one trial with 99 participants. Two other trials did not find a difference in numerical rating of anxiety (mean 1.7 (SD 2.4) for 20 participants randomized to midazolam; mean 2.6 (SD 2.9) for 22 participants randomized to placebo; P = 0.216; mean Spielberger's Trait Anxiety Inventory score 47.56 (SD 11.68) in the midazolam group; mean 52.78 (SD 9.61) in placebo group; P > 0.05). Intranasal midazolam versus placebo (2 trials; 149 participants)Midazolam induced sedation (midazolam mean 3.15 (SD 0.36); placebo mean 2.56 (SD 0.64); P < 0.001) and reduced the numerical rating of anxiety in one trial with 54 participants (midazolam mean 17.3 (SD 18.58); placebo mean 49.3 (SD 29.46); P < 0.001). There was no difference in meta-analysis of results from both trials for risk of incomplete procedures (RR 0.14, 95% CI 0.02 to 1.12; downgraded to low-quality evidence).
AUTHORS' CONCLUSIONS
We found no high-quality evidence to determine if midazolam, when administered as the sole sedative agent prior to a procedure, produces more or less effective sedation than placebo or other medications. There is low-quality evidence that intravenous midazolam reduced anxiety when compared with placebo. There is inconsistent evidence that oral midazolam decreased anxiety during procedures compared with placebo. Intranasal midazolam did not reduce the risk of incomplete procedures, although anxiolysis and sedation were observed. There is moderate-quality evidence suggesting that oral midazolam produces less effective sedation than chloral hydrate for completion of procedures for children undergoing non-invasive diagnostic procedures.
Topics: Administration, Intranasal; Administration, Oral; Adult; Anxiety; Child; Chloral Hydrate; Diagnostic Techniques and Procedures; Diazepam; Humans; Hypnotics and Sedatives; Injections, Intravenous; Midazolam; Randomized Controlled Trials as Topic; Therapeutics
PubMed: 27198122
DOI: 10.1002/14651858.CD009491.pub2 -
British Journal of Clinical Pharmacology Oct 2017Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review... (Meta-Analysis)
Meta-Analysis Review
AIMS
Aprepitant and fosaprepitant, commonly used for the prevention of chemotherapy-induced nausea and vomiting, alter cytochrome P450 activity. This systematic review evaluates clinically significant pharmacokinetic drug interactions with aprepitant and fosaprepitant and describes adverse events ascribed to drug interactions with aprepitant or fosaprepitant.
METHODS
We systematically reviewed the literature to September 11, 2016, to identify articles evaluating drug interactions involving aprepitant/fosaprepitant. The clinical significance of each reported pharmacokinetic drug interaction was evaluated based on the United States Food and Drug Administration guidance document on conducting drug interaction studies. The probability of an adverse event reported in case reports being due to a drug interaction with aprepitant/fosaprepitant was determined using the Drug Interaction Probability Scale.
RESULTS
A total of 4377 publications were identified. Of these, 64 met inclusion eligibility criteria: 34 described pharmacokinetic drug interactions and 30 described adverse events ascribed to a drug interaction. Clinically significant pharmacokinetic interactions between aprepitant/fosaprepitant and bosutinib PO, cabazitaxel IV, cyclophosphamide IV, dexamethasone PO, methylprednisolone IV, midazolam PO/IV, oxycodone PO and tolbutamide PO were identified, as were adverse events resulting from an interaction between aprepitant/fosaprepitant and alcohol, anthracyclines, ifosfamide, oxycodone, quetiapine, selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors and warfarin.
CONCLUSIONS
The potential for a drug interaction with aprepitant and fosaprepitant should be considered when selecting antiemetic therapy.
Topics: Antiemetics; Antineoplastic Agents; Aprepitant; Cytochrome P-450 CYP2C9 Inducers; Cytochrome P-450 CYP3A Inhibitors; Drug Interactions; Ethanol; Humans; Injection Site Reaction; Morpholines; Nausea; Oxycodone; Quetiapine Fumarate; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Vomiting
PubMed: 28470980
DOI: 10.1111/bcp.13322 -
Paediatric Anaesthesia Nov 2019One of the most widely used options for minimal/moderate sedation in pediatric patients is oral midazolam, as it presents an alternative to less well-accepted routes of...
One of the most widely used options for minimal/moderate sedation in pediatric patients is oral midazolam, as it presents an alternative to less well-accepted routes of administration (eg, intravenous or intranasal) of this well-known efficacious and well-tolerated short-acting benzodiazepine. A systematic review of the literature was conducted in order to identify clinical studies evaluating the effectiveness of oral midazolam for sedation in pediatric patients in the context of premedication before anesthesia or during diagnostic/treatment procedures. The percentage of responders (response rate) after single administration of oral midazolam was evaluated and compared versus placebo in a subset of placebo-controlled studies. The range of oral midazolam doses providing effective sedation in the different pediatric age subsets was analyzed in order to assess optimum dosing strategies. A total of 25 pediatric clinical studies, utilizing a variety of measures of sedation effectiveness, were selected. These studies included a total of 1472 patients (aged 4 months-18 years) treated with midazolam (0.25-1.5 mg/kg) and 138 patients treated with placebo. The response rates [95% confidence interval] with oral midazolam ranged from 36.7% [21.6%, 54.9%] to 97.8% [86.1%, 99.7%], while with placebo response rates ranged from 4.0% [0.6%, 23.5%] to 41.0% [29.4%, 53.6%]. When considering the 4 placebo-controlled studies, the odds ratios [95% confidence interval] for the comparison of midazolam vs. placebo ranged from 13.4 [5.0, 36.0] to 25.9 [6.7, 100.6]. The analysis of subgroups by context of sedation showed response rates [95% confidence interval] with oral midazolam ranging from 36.7% [21.6%, 54.9%] to 97.0% [94.8%, 98.3%] for anesthetic premedication and from 56.1% [43.1%, 68.4] to 97.8% [86.1%, 99.7%] for medical procedures. The efficacy of midazolam for pediatric minimal/moderate sedation from a dose of 0.25 mg/kg and above was demonstrated. The probability of occurrence of adverse events and over-sedation increases with increasing doses.
Topics: Administration, Intranasal; Administration, Oral; Adolescent; Child; Child, Preschool; Conscious Sedation; Humans; Hypnotics and Sedatives; Infant; Midazolam; Randomized Controlled Trials as Topic
PubMed: 31538393
DOI: 10.1111/pan.13747