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Dexmedetomidine versus Midazolam in Procedural Sedation. A Systematic Review of Efficacy and Safety.PloS One 2017To systematically review the literature comparing the efficacy and safety of dexmedetomidine and midazolam when used for procedural sedation. (Review)
Review
OBJECTIVES
To systematically review the literature comparing the efficacy and safety of dexmedetomidine and midazolam when used for procedural sedation.
MATERIALS AND METHODS
We searched MEDLINE, EMBASE and COCHRANE for clinical trials comparing dexmedetomidine and midazolam for procedural sedation up to June 20, 2016. Inclusion criteria: clinical trial, human subjects, adult subjects (≥18 years), article written in English, German, French or Dutch, use of study medication for conscious sedation and at least one group receiving dexmedetomidine and one group receiving midazolam. Exclusion criteria: patients in intensive care, pediatric subjects and per protocol use of additional sedative medication other than rescue medication. Outcome measures for efficacy comparison were patient and clinician satisfaction scores and pain scores; outcome measures for safety comparison were hypotension, hypoxia, and circulatory and respiratory complications.
RESULTS
We identified 89 papers, of which 12 satisfied the inclusion and exclusion criteria; 883 patients were included in these studies. Dexmedetomidine was associated with higher patient and operator satisfaction than midazolam. Patients receiving dexmedetomidine experienced less pain and had lower analgesic requirements. Respiratory and hemodynamic safety were similar.
CONCLUSIONS
Dexmedetomidine is a promising alternative to midazolam for use in procedural sedation. Dexmedetomidine provides more comfort during the procedure for the patient and clinician. If carefully titrated, the safety profiles are similar.
Topics: Dexmedetomidine; Hemodynamics; Humans; Hypnotics and Sedatives; Midazolam; Respiration
PubMed: 28107373
DOI: 10.1371/journal.pone.0169525 -
Journal of Critical Care Aug 2021Compare outcomes of adult patients admitted to ICU- length of ICU stay, length of mechanical ventilation (MV), and time until extubation- according to the use of... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
Compare outcomes of adult patients admitted to ICU- length of ICU stay, length of mechanical ventilation (MV), and time until extubation- according to the use of propofol versus midazolam.
METHODS
We searched MEDLINE, EMBASE, LILACS, and Cochrane databases to retrieve RCTs that compared propofol and midazolam used as sedatives in adult ICU patients. We applied a random-effects, meta-analytic model in all calculations. We applied the Cochrane collaboration tool and GRADE. We separated patients into two groups: acute surgical patients (hospitalization up to 24 h) and critically-ill patients (hospitalization over 24 h and whose articles mostly mix surgical, medical and trauma patients).
RESULTS
Globally, propofol was associated with a reduced MV time of 4.46 h (MD: -4.46 [95% CI -7.51 to -1.42] p = 0.004, I2 = 63%, 6 studies) and extubation time of 7.95 h (MD: -7.95 [95% CI -9.86 to -6.03] p < 0.00001, I2 = 98%, 16 studies). Acute surgical patients sedation with propofol compared to midazolam was associated with a reduced ICU stay of 5.07 h (MD: -5.07 [95% CI -8.68 to -1.45] p = 0.006, I2 = 41%, 5 studies), MV time of 4.28 h (MD: -4.28; [95% CI -4.62 to -3.94] p < 0.0001, I2 = 0%, 3 studies), extubation time of 1.92 h (MD: -1.92; [95% CI -2.71 to -1.13] p = 0.00001, I2 = 89%, 9 studies). In critically-ill patients sedation with propofol compared to midazolam was associated with a reduced extubation time of 32.68 h (MD: -32.68 [95% CI -48.37 to -16.98] p = 0.0001, I2 = 97%, 9 studies). GRADE was very low for all outcomes.
CONCLUSIONS
Sedation with propofol compared to midazolam is associated with improved clinical outcomes in ICU, with reduced ICU stay MV time and extubation time in acute surgical patients and reduced extubation time in critically-ill patients.
Topics: Adult; Critical Care; Humans; Hypnotics and Sedatives; Intensive Care Units; Midazolam; Propofol; Respiration, Artificial
PubMed: 33838522
DOI: 10.1016/j.jcrc.2021.04.001 -
Epilepsy & Behavior : E&B Dec 2021Acute seizure activity might cause complications including bodily harm, progression to status epilepticus, and poor quality of life in children. The introduction of a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Acute seizure activity might cause complications including bodily harm, progression to status epilepticus, and poor quality of life in children. The introduction of a venous line may be difficult in children with seizures which would delay the initiation of treatment. Rectal drug administration can be socially awkward for patients and providers. Intranasal (IN) midazolam offers a valuable substitute that is easier and faster to administer.
OBJECTIVE
To assess the efficacy, safety, and acceptability of intranasal midazolam in children with acute seizure when compared to conventional IV or rectal benzodiazepine (BDZ).
METHODS
PubMed, google scholar, websites clinicaltrials.gov and the WHO-international clinical trials registry platform, were searched. Randomized controlled/prospective randomized trials comparing IN midazolam against IV/rectal BDZ in the treatment of acute seizures in pediatric patients were included in the meta-analysis.
RESULTS
Data of 10 studies were quantitatively analyzed. Intranasal midazolam (n = 169) when compared to IV/rectal BDZ (n = 161) has a shorter interval between hospital arrival and seizure cessation {(mean difference = -3.51; 95% CI [-6.84, -0.18]) P = 0.04}. Regarding time to seizure cessation after midazolam (n = 326) or BDZ (n = 322) administration, there is no significant difference between the two groups {(mean difference = -0.03; 95% CI [-1.30, 1.25]), P = 0.97} and both are equally effective for controlling acute seizures (odds ratio = 1.06; 95% CI [0.43, 2.63]; n = 737).
CONCLUSION
In children with acute seizures, IN midazolam is equally effective in aborting seizure and decreases the total time from hospital arrival and cessation of seizures, eventually leading to faster cessation of seizure as compared to IV/rectal BDZ.
Topics: Administration, Intranasal; Anticonvulsants; Benzodiazepines; Child; Diazepam; Humans; Midazolam; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Seizures; Status Epilepticus
PubMed: 34740090
DOI: 10.1016/j.yebeh.2021.108390 -
Epilepsia Oct 2023Seizures are common in neonates, but there is substantial management variability. The Neonatal Task Force of the International League Against Epilepsy (ILAE) developed... (Meta-Analysis)
Meta-Analysis
Seizures are common in neonates, but there is substantial management variability. The Neonatal Task Force of the International League Against Epilepsy (ILAE) developed evidence-based recommendations about antiseizure medication (ASM) management in neonates in accordance with ILAE standards. Six priority questions were formulated, a systematic literature review and meta-analysis were performed, and results were reported following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 standards. Bias was evaluated using the Cochrane tool and risk of Bias in non-randomised studies - of interventions (ROBINS-I), and quality of evidence was evaluated using grading of recommendations, assessment, development and evaluation (GRADE). If insufficient evidence was available, then expert opinion was sought using Delphi consensus methodology. The strength of recommendations was defined according to the ILAE Clinical Practice Guidelines development tool. There were six main recommendations. First, phenobarbital should be the first-line ASM (evidence-based recommendation) regardless of etiology (expert agreement), unless channelopathy is likely the cause for seizures (e.g., due to family history), in which case phenytoin or carbamazepine should be used. Second, among neonates with seizures not responding to first-line ASM, phenytoin, levetiracetam, midazolam, or lidocaine may be used as a second-line ASM (expert agreement). In neonates with cardiac disorders, levetiracetam may be the preferred second-line ASM (expert agreement). Third, following cessation of acute provoked seizures without evidence for neonatal-onset epilepsy, ASMs should be discontinued before discharge home, regardless of magnetic resonance imaging or electroencephalographic findings (expert agreement). Fourth, therapeutic hypothermia may reduce seizure burden in neonates with hypoxic-ischemic encephalopathy (evidence-based recommendation). Fifth, treating neonatal seizures (including electrographic-only seizures) to achieve a lower seizure burden may be associated with improved outcome (expert agreement). Sixth, a trial of pyridoxine may be attempted in neonates presenting with clinical features of vitamin B6-dependent epilepsy and seizures unresponsive to second-line ASM (expert agreement). Additional considerations include a standardized pathway for the management of neonatal seizures in each neonatal unit and informing parents/guardians about the diagnosis of seizures and initial treatment options.
Topics: Infant, Newborn; Humans; Anticonvulsants; Levetiracetam; Phenytoin; Consensus; Epilepsy; Seizures
PubMed: 37655702
DOI: 10.1111/epi.17745 -
Annals of Internal Medicine Sep 2019Suicide is a growing public health problem, with the national rate in the United States increasing by 30% from 2000 to 2016.
BACKGROUND
Suicide is a growing public health problem, with the national rate in the United States increasing by 30% from 2000 to 2016.
PURPOSE
To assess the benefits and harms of nonpharmacologic and pharmacologic interventions to prevent suicide and reduce suicide behaviors in at-risk adults.
DATA SOURCES
MEDLINE, EMBASE, PsycINFO, and other databases from November 2011 through May 2018.
STUDY SELECTION
Systematic reviews (SRs) and randomized controlled trials (RCTs) that assessed nonpharmacologic or pharmacologic therapies for adults at risk for suicide.
DATA EXTRACTION
One investigator abstracted data and assessed study quality, and a second investigator checked abstractions and assessments for accuracy.
DATA SYNTHESIS
Eight SRs and 15 RCTs were included. The evidence for psychological interventions suggests that cognitive behavioral therapy (CBT) reduces suicide attempts, suicidal ideation, and hopelessness compared with treatment as usual (TAU). Limited evidence suggests that dialectical behavior therapy (DBT) reduces suicidal ideation compared with wait-list control or crisis planning. The evidence for pharmacologic treatments suggests that ketamine reduces suicidal ideation with minimal adverse events compared with placebo or midazolam. Lithium reduces rates of suicide among patients with unipolar or bipolar mood disorders compared with placebo. However, no differences were observed between lithium and other medications in reducing suicide.
LIMITATION
Qualitative synthesis of new evidence with existing meta-analyses, methodological shortcomings of studies, heterogeneity of nonpharmacologic interventions, and limited evidence for pharmacologic treatments and harms.
CONCLUSION
Both CBT and DBT showed modest benefit in reducing suicidal ideation compared with TAU or wait-list control, and CBT also reduced suicide attempts compared with TAU. Ketamine and lithium reduced the rate of suicide compared with placebo, but there was limited information on harms. Limited data are available to support the efficacy of other nonpharmacologic or pharmacologic interventions.
PRIMARY FUNDING SOURCE
U.S. Department of Veterans Affairs Veterans Health Administration. (PROSPERO: CRD42018104978).
Topics: Antidepressive Agents; Cognitive Behavioral Therapy; Crisis Intervention; Dialectical Behavior Therapy; Humans; Ketamine; Lithium Compounds; Patient Education as Topic; Risk Factors; Suicidal Ideation; Suicide; United States; Suicide Prevention
PubMed: 31450239
DOI: 10.7326/M19-0869 -
Journal of Pain and Symptom Management Apr 2021Near the end of life when patients experience refractory symptoms, palliative sedation may be considered as a last treatment. Clinical guidelines have been developed,... (Review)
Review
CONTEXT
Near the end of life when patients experience refractory symptoms, palliative sedation may be considered as a last treatment. Clinical guidelines have been developed, but they are mainly based on expert opinion or retrospective chart reviews. Therefore, evidence for the clinical aspects of palliative sedation is needed.
OBJECTIVES
To explore clinical aspects of palliative sedation in recent prospective studies.
METHODS
Systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered at PROSPERO. PubMed, CINAHL, Cochrane, MEDLINE, and EMBASE were searched (January 2014-December 2019), combining sedation, palliative care, and prospective. Article quality was assessed.
RESULTS
Ten prospective articles were included, involving predominantly patients with cancer. Most frequently reported refractory symptoms were delirium (41%-83%), pain (25%-65%), and dyspnea (16%-59%). In some articles, psychological and existential distress were mentioned (16%-59%). Only a few articles specified the tools used to assess symptoms. Level of sedation assessment tools were the Richmond Agitation Sedation Scale, Ramsay Sedation Scale, Glasgow Coma Scale, and Bispectral Index monitoring. The palliative sedation practice shows an underlying need for proportionality in relation to symptom intensity. Midazolam was the main sedative used. Other reported medications were phenobarbital, promethazine, and anesthetic medication-propofol. The only study that reported level of patient's discomfort as a palliative sedation outcome showed a decrease in patient discomfort.
CONCLUSION
Assessment of refractory symptoms should include physical evaluation with standardized tools applied and interviews for psychological and existential evaluation by expert clinicians working in teams. Future research needs to evaluate the effectiveness of palliative sedation for refractory symptom relief.
Topics: Hospice and Palliative Care Nursing; Humans; Hypnotics and Sedatives; Palliative Care; Prospective Studies; Retrospective Studies; Terminal Care
PubMed: 32961218
DOI: 10.1016/j.jpainsymman.2020.09.022 -
Pain Physician May 2019Postherpetic neuralgia, a persistent pain condition often characterized by allodynia and hyperalgesia, is a deleterious consequence experienced by patients after an...
BACKGROUND
Postherpetic neuralgia, a persistent pain condition often characterized by allodynia and hyperalgesia, is a deleterious consequence experienced by patients after an acute herpes zoster vesicular eruption has healed. The pain associated with postherpetic neuralgia can severely affect a patient's quality of life, quality of sleep, and ability to participate in activities of daily living. Currently, first-line treatments for this condition include the administration of medication therapies such as tricyclic antidepressants, pregabalin, gabapentin, and lidocaine patches, followed by the application of tramadol and capsaicin creams and patches as second- or third-line therapies. As not all patients respond to such conservative options, however, interventional therapies are valuable for those who continue to experience pain.
OBJECTIVE
This review focuses on interventional therapies that have been subjected to randomized controlled trials for the treatment of postherpetic neuralgia, including transcutaneous electrical nerve stimulation; local botulinum toxin A, cobalamin, and triamcinolone injection; intrathecal methylprednisolone and midazolam injection; stellate ganglion block; dorsal root ganglion destruction; and pulsed radiofrequency therapy.
STUDY DESIGN
Systematic review.
SETTING
Hospital department in Taiwan.
METHODS
Search of PubMed database for all randomized controlled trials regarding postherpetic neuralgia that were published before the end of May 2017.
RESULTS
The current evidence is insufficient for determining the single best interventional treatment. Considering invasiveness, price, and safety, the subcutaneous injection of botulinum toxin A or triamcinolone, transcutaneous electrical nerve stimulation, peripheral nerve stimulation, and stellate ganglion block are recommended first, followed by paravertebral block and pulsed radiofrequency. If severe pain persists, spinal cord stimulation could be considered. Given the destructiveness of dorsal root ganglion and adverse events of intrathecal methylprednisolone injection, these interventions should be carried out with great care and only following comprehensive discussion.
LIMITATIONS
Although few adverse effects were reported, these procedures are invasive, and a careful assessment of the risk-benefit ratio should be conducted prior to administration.
CONCLUSION
With the exception of intrathecal methylprednisolone injection for postherpetic neuralgia, the evidence for most interventional procedures used to treat postherpetic neuralgia is Level 2, according to "The Oxford Levels of Evidence 2". Therefore, these modalities have received only grade B recommendations. Despite the lack of a high level of evidence, spinal cord stimulation and peripheral nerve stimulation are possibly useful for the treatment of postherpetic neuralgia.
KEY WORDS
Interventional treatment, postherpetic neuralgia, botulinum toxin, steroid, stellate ganglion block, peripheral nerve stimulation, paravertebral block, radiofrequency, spinal cord stimulation.
Topics: Female; Humans; Male; Neuralgia, Postherpetic; Pain Management; Randomized Controlled Trials as Topic
PubMed: 31151330
DOI: No ID Found -
The Journal of Emergency Medicine Oct 2017Chlorpromazine is the only drug approved by the US Food and Drug Administration for the treatment of hiccups; however, many other pharmacologic treatments have been... (Review)
Review
BACKGROUND
Chlorpromazine is the only drug approved by the US Food and Drug Administration for the treatment of hiccups; however, many other pharmacologic treatments have been proposed for intractable and persistent hiccups. Currently, there is little evidence to support the use of one agent over another.
OBJECTIVE
This review aims to identify literature concerning the use of pharmacologic treatments for intractable and persistent hiccups with the goal of evaluating therapies in terms of their level of evidence, mechanism of action, efficacy, dosing, onset of action, and adverse effects.
METHODS
A systematic literature search of PubMed, Embase, the Cochrane Library, and the New York Academy of Medicine was performed to find articles where a pharmacologic agent was used to treat intractable or persistent hiccups between the years 1966 and 2016. The GRADE method was used to assess the level of evidence for the studies included in this review.
RESULTS
This review identified 26 articles involving 10 pharmacologic treatment options that met our inclusion criteria. Amitriptyline, baclofen, gabapentin, haloperidol, metoclopramide, midazolam, nifedipine, nimodipine, orphenadrine, and valproic acid were found in the literature to be successful in treating hiccups.
CONCLUSION
Baclofen, gabapentin, and metoclopramide were the only agents that were studied in a prospective manner, while only baclofen and metoclopramide were studied in randomized controlled trials. No specific recommendations can be made for treating intractable and persistent hiccups with the evidence currently available in the literature. Therapy selection should be specific to individual patients, their underlying comorbidities, etiology of hiccups, and take into account the individual properties of the drugs.
Topics: Adrenergic Uptake Inhibitors; Chlorpromazine; Dopamine Antagonists; Dopamine D2 Receptor Antagonists; Emergency Service, Hospital; GABA-B Receptor Agonists; Hiccup; Humans
PubMed: 29079070
DOI: 10.1016/j.jemermed.2017.05.033 -
Seizure May 2019To summarize definitions, prevalence, risk factors, consequences, and acute management of seizure clusters using rescue medications.
PURPOSE
To summarize definitions, prevalence, risk factors, consequences, and acute management of seizure clusters using rescue medications.
METHODS
We searched MEDLINE for studies that assessed definitions, clinical characteristics, outcomes, and use of rescue medication for aborting seizure clusters.
RESULTS
Different clinical and statistical definitions for seizure clusters have been proposed, including: ≥3 seizures in 24 h, ≥2 seizures in 24 h, and ≥2 seizures in 6 h. Most studies of seizure clusters have been conducted in tertiary epilepsy centers, with refractory epilepsy patients. Patients with severe and poorly controlled epilepsy are more likely to experience seizure clusters. Seizure clusters can result in increased health care utilization and have negative impact on the quality of life of patients and caregivers. Use of benzodiazepine rescue medications in acute management of seizure clusters can help avoid progression to status epilepticus and reduce emergency room visits. Rescue medications are underutilized in seizure clusters. Currently, rectal diazepam gel is the only FDA approved rescue medication for seizure clusters. In addition, buccal midazolam is approved in European countries for treatment of prolonged seizures. However, various non-rectal non-IV benzodiazepines are safe and effective in treating acute seizures and clusters. Most patients and caregivers preferred non-rectal routes.
CONCLUSION
Identifying patients that are at high risk for seizure clusters, providing them with formal action plans and educating them about use of rescue medication for seizure clusters can help ameliorate the outcomes in this group of epilepsy patients.
Topics: Adolescent; Adult; Aged; Child; Child, Preschool; Epilepsy; Humans; Infant; Middle Aged; Seizures; Young Adult
PubMed: 29871784
DOI: 10.1016/j.seizure.2018.05.013 -
The Cochrane Database of Systematic... Jun 2013Patients awaiting surgical procedures often experience significant anxiety. Such anxiety may result in negative physiological manifestations, slower wound healing,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Patients awaiting surgical procedures often experience significant anxiety. Such anxiety may result in negative physiological manifestations, slower wound healing, increased risk of infection, and may complicate the induction of anaesthesia and impede postoperative recovery. To reduce patient anxiety, sedatives and anti-anxiety drugs are regularly administered before surgery. However, these often have negative side effects and may prolong patient recovery. Therefore, increasing attention is being paid to a variety of non-pharmacological interventions for reduction of preoperative anxiety such as music therapy and music medicine interventions. Interventions are categorized as 'music medicine' when passive listening to pre-recorded music is offered by medical personnel. In contrast, music therapy requires the implementation of a music intervention by a trained music therapist, the presence of a therapeutic process, and the use of personally tailored music experiences. A systematic review was needed to gauge the efficacy of both music therapy and music medicine interventions for reduction of preoperative anxiety.
OBJECTIVES
To examine the effects of music interventions with standard care versus standard care alone on preoperative anxiety in surgical patients.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1950 to August 2012), CINAHL (1980 to August 2012), AMED (1985 to April 2011; we no longer had access to AMED after this date), EMBASE (1980 to August 2012), PsycINFO (1967 to August 2012), LILACS (1982 to August 2012), Science Citation Index (1980 to August 2012), the specialist music therapy research database (March 1 2008; database is no longer functional), CAIRSS for Music (to August 2012), Proquest Digital Dissertations (1980 to August 2012), ClinicalTrials.gov (2000 to August 2012), Current Controlled Trials (1998 to August 2012), and the National Research Register (2000 to September 2007). We handsearched music therapy journals and reference lists, and contacted relevant experts to identify unpublished manuscripts. There was no language restriction.
SELECTION CRITERIA
We included all randomized and quasi-randomized trials that compared music interventions and standard care with standard care alone for reducing preoperative anxiety in surgical patients.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted the data and assessed the risk of bias. We contacted authors to obtain missing data where needed. Where possible, results were presented in meta analyses using mean differences and standardized mean differences. Post-test scores were used. In cases of significant baseline differences, we used change scores.
MAIN RESULTS
We included 26 trials (2051 participants). All studies used listening to pre-recorded music. The results suggested that music listening may have a beneficial effect on preoperative anxiety. Specifically, music listening resulted, on average, in an anxiety reduction that was 5.72 units greater (95% CI -7.27 to -4.17, P < 0.00001) than that in the standard care group as measured by the Stait-Trait Anxiety Inventory (STAI-S), and -0.60 standardized units (95% CI -0.90 to -0.31, P < 0.0001) on other anxiety scales. The results also suggested a small effect on heart rate and diastolic blood pressure, but no support was found for reductions in systolic blood pressure, respiratory rate, and skin temperature. Most trials were assessed to be at high risk of bias because of lack of blinding. Blinding of outcome assessors is often impossible in music therapy and music medicine studies that use subjective outcomes, unless in studies in which the music intervention is compared to another treatment intervention. Because of the high risk of bias, these results need to be interpreted with caution.None of the studies included wound healing, infection rate, time to discharge, or patient satisfaction as outcome variables. One large study found that music listening was more effective than the sedative midazolam in reducing preoperative anxiety and equally effective in reducing physiological responses. No adverse effects were identified.
AUTHORS' CONCLUSIONS
This systematic review indicates that music listening may have a beneficial effect on preoperative anxiety. These findings are consistent with the findings of three other Cochrane systematic reviews on the use of music interventions for anxiety reduction in medical patients. Therefore, we conclude that music interventions may provide a viable alternative to sedatives and anti-anxiety drugs for reducing preoperative anxiety.
Topics: Anxiety; Blood Pressure; Heart Rate; Humans; Music Therapy; Preoperative Care; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 23740695
DOI: 10.1002/14651858.CD006908.pub2