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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 -
PloS One 2015To assess the efficacy of midazolam for anxiety control in third molar extraction surgery. (Review)
Review
PURPOSE
To assess the efficacy of midazolam for anxiety control in third molar extraction surgery.
METHODS
Electronic retrievals were conducted in Medline (via PubMed, 1950-2013.12), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2013, Issue 3), Embase (via OVID 1974-2013.12), and the System for Information on Grey Literature in Europe (SIGLE). The bibliographies of relevant clinical trials were also checked. Randomized controlled trials satisfying the inclusion criteria were evaluated, with data extraction done independently by two well-trained investigators. Disagreements were resolved by discussion or by consultation with a third member of the review team.
RESULTS
Ten studies were included, but meta-analysis could not be conducted because of the significant differences among articles. All but one article demonstrated that midazolam could relieve anxiety. One article demonstrated that propofol offered superior anxiolysis, with more rapid recovery than with midazolam. Compared with lorazepam and diazepam, midazolam did not distinctly dominate in its sedative effect, but was safer. Two articles used midazolam in multidrug intravenous sedation and proved it to be more effective than midazolam alone.
CONCLUSION
It was found, by comparison and analysis, that midazolam might be effective for use for anxiety control during third molar extraction and can be safely administered by a dedicated staff member. It can also be used with other drugs to obtain better sedative effects, but the patient's respiratory function must be monitored closely, because multidrug sedation is also more risky.
Topics: Anti-Anxiety Agents; Anxiety; Clinical Trials as Topic; Female; Humans; MEDLINE; Male; Midazolam; Molar; Tooth Extraction
PubMed: 25849859
DOI: 10.1371/journal.pone.0121410 -
Journal of Child Neurology Aug 2009Pediatric prolonged seizures and status epilepticus are medical emergencies necessitating immediate life-support and seizure-control measures. A systematic review of... (Review)
Review
Pediatric prolonged seizures and status epilepticus are medical emergencies necessitating immediate life-support and seizure-control measures. A systematic review of published data on the management of prolonged seizures and status epilepticus showed that buccal midazolam was significantly more effective than rectal diazepam, reaching a seizure-control rate of 70% and recurrence rate of 8%. Intranasal lorazepam was as effective as intramuscular paraldehyde in a cost-restrained setting. In refractory status epilepticus, both intravenous midazolam and valproate were equally effective to intravenous diazepam, with valproate exhibiting significantly faster seizure cessation and safer profile than diazepam, even in infancy. In conclusion, buccal midazolam is efficacious and safe thanks to its convenient route of administration, which may serve as first-line in the treatment of prolonged seizures. Intranasal lorazepam is an effective, easy-to-use, and safe drug for prolonged seizures. Intravenous valproate exhibits favorable efficacy and safety profile as third-line in status epilepticus, refractory to diazepam and phenytoin.
Topics: Anticonvulsants; Child; Humans; Seizures; Status Epilepticus
PubMed: 19332572
DOI: 10.1177/0883073809332768 -
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 -
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 -
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 -
Gastrointestinal Endoscopy May 2008Numerous agents are available for moderate sedation in endoscopy. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Numerous agents are available for moderate sedation in endoscopy.
OBJECTIVE
Our purpose was to compare efficacy, safety, and efficiency of agents used for moderate sedation in EGD or colonoscopy.
DESIGN
Systematic review of computerized bibliographic databases for randomized trials of moderate sedation that compared 2 active regimens or 1 active regimen with placebo or no sedation.
PATIENTS
Unselected adults undergoing EGD or colonoscopy with a goal of moderate sedation.
MAIN OUTCOME MEASUREMENTS
Sedation-related complications, patient assessments (satisfaction, pain, memory, willingness to repeat examination), physician assessments (satisfaction, level of sedation, patient cooperation, examination quality), and procedure-related efficiency outcomes (sedation, procedure, or recovery time).
RESULTS
Thirty-six studies (N = 3918 patients) were included. Sedation improved patient satisfaction (relative risk [RR] = 2.29, range 1.16-4.53) and willingness to repeat EGD (RR = 1.25, range 1.13-1.38) versus no sedation. Midazolam provided superior patient satisfaction to diazepam (RR = 1.18, range 1.07-1.29) and less frequent memory of EGD (RR = 0.57, range 0.50-0.60) versus diazepam. Adverse events and patient/physician assessments were not significantly different for midazolam (with or without narcotics) versus propofol except for slightly less patient satisfaction (RR = 0.90, range 0.83-0.97) and more frequent memory (RR = 3.00, range 1.25-7.21) with midazolam plus narcotics. Procedure times were similar, but sedation and recovery times were shorter with propofol than midazolam-based regimens.
LIMITATIONS
Marked variability in design, regimens tested, and outcomes assessed; relatively poor methodologic quality (Jadad score =3 in 23/36 trials).
CONCLUSIONS
Moderate sedation provides a high level of physician and patient satisfaction and a low risk of serious adverse events with all currently available agents. Midazolam-based regimens have longer sedation and recovery times than does propofol.
Topics: Conscious Sedation; Digestive System Diseases; Endoscopy, Digestive System; Humans; Randomized Controlled Trials as Topic
PubMed: 18440381
DOI: 10.1016/j.gie.2007.12.046 -
BMJ Clinical Evidence Oct 2007Up to 40% of adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking. The prevalence of insomnia increases with age. Other... (Review)
Review
INTRODUCTION
Up to 40% of adults have insomnia, with difficulty getting to sleep, early waking, or feeling unrefreshed on waking. The prevalence of insomnia increases with age. Other risk factors include psychological factors, stress, daytime napping, and hyperarousal.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of non-drug treatments for insomnia in elderly people? What are the effects of drug treatments for insomnia in elderly people? We searched: Medline, Embase, The Cochrane Library and other important databases up to October 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 28 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: benzodiazepines (brotizolam, flurazepam, loprazolam, midazolam, nitrazepam, quazepam, temazepam, and triazolam), cognitive behavioural therapy, diphenhydramine, exercise programmes, timed exposure to bright light, zaleplon, zolpidem, and zopiclone.
Topics: Aged; Cognitive Behavioral Therapy; Flurazepam; Humans; Risk Factors; Sleep; Sleep Initiation and Maintenance Disorders; Temazepam
PubMed: 19450355
DOI: No ID Found -
Obesity Reviews : An Official Journal... May 2024To evaluate the impact of bariatric surgery on the pharmacokinetic (PK) parameters of orally administered medications and supplements. (Review)
Review
OBJECTIVES
To evaluate the impact of bariatric surgery on the pharmacokinetic (PK) parameters of orally administered medications and supplements.
METHODS
Systematic searches of bibliographic databases were conducted to identify studies. Pooled effect estimates from different surgical procedures were calculated using a random-effects model.
RESULTS
Quantitative data were synthesized from 58 studies including a total of 1985 participants. Whilst 40 medications and 6 supplements were evaluated across these studies, heterogeneity and missing information reduced the scope of the meta-analysis to the following medications and supplements: atorvastatin, paracetamol, omeprazole, midazolam, vitamin D, calcium, zinc, and iron supplements. There were no significant differences in PK parameters post-surgery for the drugs atorvastatin and omeprazole, and supplements calcium, ferritin, and zinc supplements. Paracetamol showed reduced clearance (mean difference [MD] = -15.56 L/hr, p = 0.0002, I = 67%), increased maximal concentration (MD = 6.90 μg/ml, p = 0.006, I = 92%) and increased terminal elimination half-life (MD = 0.49 hr, p < 0.0001, I = 3%) post-surgery. The remaining 36 medications and 2 supplements were included in a systematic review. Overall, 18 of the 53 drugs and supplements showed post-operative changes in PK parameters.
CONCLUSION
This study demonstrates heterogeneity in practice and could not reach conclusive findings for most PK parameters. Prospective studies are needed to inform best practice and enhance patient healthcare and safety following bariatric surgery.
PubMed: 38710656
DOI: 10.1111/obr.13759 -
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