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  1. Fong CY, Lim WK, Li L, Lai NM
    Cochrane Database Syst Rev, 2021 08 16;8:CD011786.
    PMID: 34397100 DOI: 10.1002/14651858.CD011786.pub3
    BACKGROUND: This is an updated version of a Cochrane Review published in 2017. Paediatric neurodiagnostic investigations, including brain neuroimaging and electroencephalography (EEG), play an important role in the assessment of neurodevelopmental disorders. The use of an appropriate sedative agent is important to ensure the successful completion of the neurodiagnostic procedures, particularly in children, who are usually unable to remain still throughout the procedure.

    OBJECTIVES: To assess the effectiveness and adverse effects of chloral hydrate as a sedative agent for non-invasive neurodiagnostic procedures in children.

    SEARCH METHODS: We searched the following databases on 14 May 2020, with no language restrictions: the Cochrane Register of Studies (CRS Web) and MEDLINE (Ovid, 1946 to 12 May 2020). CRS Web includes randomised or quasi-randomised controlled trials from PubMed, Embase, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform, the Cochrane Central Register of Controlled Trials (CENTRAL), and the specialised registers of Cochrane Review Groups including Cochrane Epilepsy.

    SELECTION CRITERIA: Randomised controlled trials that assessed chloral hydrate agent against other sedative agent(s), non-drug agent(s), or placebo.

    DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated studies identified by the search for their eligibility, extracted data, and assessed risk of bias. Results were expressed in terms of risk ratio (RR) for dichotomous data and mean difference (MD) for continuous data, with 95% confidence intervals (CIs).

    MAIN RESULTS: We included 16 studies with a total of 2922 children. The methodological quality of the included studies was mixed. Blinding of the participants and personnel was not achieved in most of the included studies, and three of the 16 studies were at high risk of bias for selective reporting. Evaluation of the efficacy of the sedative agents was also underpowered, with all the comparisons performed in small studies. Fewer children who received oral chloral hydrate had sedation failure compared with oral promethazine (RR 0.11, 95% CI 0.01 to 0.82; 1 study; moderate-certainty evidence). More children who received oral chloral hydrate had sedation failure after one dose compared to intravenous pentobarbital (RR 4.33, 95% CI 1.35 to 13.89; 1 study; low-certainty evidence), but there was no clear difference after two doses (RR 3.00, 95% CI 0.33 to 27.46; 1 study; very low-certainty evidence). Children with oral chloral hydrate had more sedation failure compared with rectal sodium thiopental (RR 1.33, 95% CI 0.60 to 2.96; 1 study; moderate-certainty evidence) and music therapy (RR 17.00, 95% CI 2.37 to 122.14; 1 study; very low-certainty evidence). Sedation failure rates were similar between groups for comparisons with oral dexmedetomidine, oral hydroxyzine hydrochloride, oral midazolam and oral clonidine. Children who received oral chloral hydrate had a shorter time to adequate sedation compared with those who received oral dexmedetomidine (MD -3.86, 95% CI -5.12 to -2.6; 1 study), oral hydroxyzine hydrochloride (MD -7.5, 95% CI -7.85 to -7.15; 1 study), oral promethazine (MD -12.11, 95% CI -18.48 to -5.74; 1 study) (moderate-certainty evidence for three aforementioned outcomes), rectal midazolam (MD -95.70, 95% CI -114.51 to -76.89; 1 study), and oral clonidine (MD -37.48, 95% CI -55.97 to -18.99; 1 study) (low-certainty evidence for two aforementioned outcomes). However, children with oral chloral hydrate took longer to achieve adequate sedation when compared with intravenous pentobarbital (MD 19, 95% CI 16.61 to 21.39; 1 study; low-certainty evidence), intranasal midazolam (MD 12.83, 95% CI 7.22 to 18.44; 1 study; moderate-certainty evidence), and intranasal dexmedetomidine (MD 2.80, 95% CI 0.77 to 4.83; 1 study, moderate-certainty evidence). Children who received oral chloral hydrate appeared significantly less likely to complete neurodiagnostic procedure with child awakening when compared with rectal sodium thiopental (RR 0.95, 95% CI 0.83 to 1.09; 1 study; moderate-certainty evidence). Chloral hydrate was associated with a higher risk of the following adverse events: desaturation versus rectal sodium thiopental (RR 5.00, 95% 0.24 to 102.30; 1 study), unsteadiness versus intranasal dexmedetomidine (MD 10.21, 95% CI 0.58 to 178.52; 1 study), vomiting versus intranasal dexmedetomidine (MD 10.59, 95% CI 0.61 to 185.45; 1 study) (low-certainty evidence for aforementioned three outcomes), and crying during administration of sedation versus intranasal dexmedetomidine (MD 1.39, 95% CI 1.08 to 1.80; 1 study, moderate-certainty evidence). Chloral hydrate was associated with a lower risk of the following: diarrhoea compared with rectal sodium thiopental (RR 0.04, 95% CI 0.00 to 0.72; 1 study), lower mean diastolic blood pressure compared with sodium thiopental (MD 7.40, 95% CI 5.11 to 9.69; 1 study), drowsiness compared with oral clonidine (RR 0.44, 95% CI 0.30 to 0.64; 1 study), vertigo compared with oral clonidine (RR 0.15, 95% CI 0.01 to 2.79; 1 study) (moderate-certainty evidence for aforementioned four outcomes), and bradycardia compared with intranasal dexmedetomidine (MD 0.17, 95% CI 0.05 to 0.59; 1 study; high-certainty evidence). No other adverse events were significantly associated with chloral hydrate, although there was an increased risk of combined adverse events overall (RR 7.66, 95% CI 1.78 to 32.91; 1 study; low-certainty evidence).

    AUTHORS' CONCLUSIONS: The certainty of evidence for the comparisons of oral chloral hydrate against several other methods of sedation was variable. Oral chloral hydrate appears to have a lower sedation failure rate when compared with oral promethazine. Sedation failure was similar between groups for other comparisons such as oral dexmedetomidine, oral hydroxyzine hydrochloride, and oral midazolam. Oral chloral hydrate had a higher sedation failure rate when compared with intravenous pentobarbital, rectal sodium thiopental, and music therapy. Chloral hydrate appeared to be associated with higher rates of adverse events than intranasal dexmedetomidine. However, the evidence for the outcomes for oral chloral hydrate versus intravenous pentobarbital, rectal sodium thiopental, intranasal dexmedetomidine, and music therapy was mostly of low certainty, therefore the findings should be interpreted with caution. Further research should determine the effects of oral chloral hydrate on major clinical outcomes such as successful completion of procedures, requirements for an additional sedative agent, and degree of sedation measured using validated scales, which were rarely assessed in the studies included in this review. The safety profile of chloral hydrate should be studied further, especially for major adverse effects such as oxygen desaturation.

    Matched MeSH terms: Midazolam/adverse effects
  2. Teah MK, Chan GK, Wong MTF, Yeap TB
    BMJ Case Rep, 2021 Jan 08;14(1).
    PMID: 33419751 DOI: 10.1136/bcr-2020-238318
    Prolonged exposure to benzodiazepines (BDZ) may contribute towards physical dependence, which is manifested by iatrogenic Benzodiazepine Withdrawal Syndrome (BWS), a condition often underdiagnosed. Current evidence recommends precluding BDZ infusion as sedation in the intensive care unit to avoid possible withdrawal and delirium issues. Administration of dexmedetomidine should be considered to facilitate weaning in patients with BWS.
    Matched MeSH terms: Midazolam/adverse effects*
  3. Chandrasekaran PK
    Singapore Med J, 2008 Jun;49(6):e166-7.
    PMID: 18581012
    Insomnia and depression are frequently encountered in patients during withdrawal from substances. While there are no approved medications for treating them, off-label attempts to address these phenomena with mirtazapine have shown some promising results. This case describes the use of mirtazapine as an aid in benzodiazepine withdrawal and its potential benefits in alleviating insomnia and depression in a 32-year-old man. It was found to ameliorate sleep myoclonus that was thought to be associated with his withdrawal syndrome. It is hoped this report will generate interest and stimulate further research in this area of psychopharmacology.
    Matched MeSH terms: Midazolam/adverse effects*
  4. Ma WT, Mahadeva S, Quek KF, Goh KL
    Med J Malaysia, 2007 Oct;62(4):313-8.
    PMID: 18551936 MyJurnal
    Tolerance to colonoscopy varies between populations and data from the South East Asian region is lacking. We aimed to determine tolerance and safety with to colonoscopy; conscious sedation and identify risk factors for complications in Malaysian adults. Consecutive outpatients undergoing colonoscopy were enrolled prospectively. A combination of pethidine and midazolam were used and tolerance to colonoscopy assessed three hours post-procedure using a validated scale. All patients were monitored for cardiorespiratory depression and risk factors for complications were identified. Two hundred and eight patients (mean age 57.2 +/- 14.8 years, 48% female) were enrolled. The population ethnicity consisted of 45 (21.63%) Malays, 101 (48.56%) Chinese and 56 (26.92%) Indians. Conscious sedation was achieved with 5.0 +/- 1.1 mg of midazolam and 43.3 +/- 14.0 mg of pethidine. Thirty (14.4%) patients tolerated the procedure poorly and independent predictors included female gender (OR 2.93, 95% CI = 1.22 to 7.01) and a prolonged duration of procedure (OR 2.85, 95% CI = 1.08 to 7.48). Hypotension occurred in 13 (6.25%) patients, with age > 65 years as the only risk factor (OR 13.17, 95% CI = 1.28 to 137.92). A prolonged duration was the main cause of hypoxia (OR 5.49, 95% CI = 1.54 to 19.49), which occurred in 6 (2.88%) patients. No major complications occurred during the study period. The current practice of conscious sedation is safe and tolerated well by most adults in our population. However, poor tolerance in a notable minority may have significant clinical implications.

    Study site: Division of Gastroenterology, Department of Medicine, University Malaya Medical Centre (UMMC)
    Matched MeSH terms: Midazolam/adverse effects*
  5. Ramanathan R
    Med J Malaysia, 1998 Sep;53 Suppl A:99-101.
    PMID: 10968190
    We studied 95 patients who underwent knee Arthroscopy under local anaesthesia between JANUARY 1995 till 1997. Materials used were 1% Xylocaine and 0.25% Bupivacaine of 20 mls each combined with midazolam 2 mg and IV pethidine 30 mgm for sedation. The patients were attached to monitors (pulse Oxymeter, ECG and BP and pulse recorders) and blood less field was created using a tornquet. The procedures lasted about 45 minutes. 90 out of 95 patients completed the procedures successfully without any complications. 2 developed respiratory embarrassments and were intubated and ventilated. 3 procedures abandoned and converted to general anaesthesia. The range of procedures done include meniscectomy, meniscal repair, synovial biopsy, debridement for osteoarthrosis, shaving of osteophytes, drilling of cartilage and bones and removal of loose bodies. This study is to show that knee arthroscopy under LA is a safe alternative in hospitals where GA time is limited.
    Matched MeSH terms: Midazolam/adverse effects
  6. Nisa K, Lim SY, Osuga T, Yokoyama N, Tamura M, Nagata N, et al.
    J Vet Med Sci, 2018 Mar 24;80(3):453-459.
    PMID: 29398670 DOI: 10.1292/jvms.17-0525
    Quantitative contrast-enhanced ultrasonography (CEUS) enables non-invasive and objective evaluation of intestinal perfusion by quantifying the intensity of enhancement on the intestine after microbubble contrast administration. During CEUS scanning, sedation is sometimes necessary to maintain animal cooperation. Nevertheless, the effect of sedative administration on the canine intestinal CEUS is unknown. This study aimed to investigate the effect of sedation with a combination of butorphanol and midazolam on the duodenal CEUS-derived perfusion parameters of healthy dogs. For this purpose, duodenum was imaged following contrast administration (Sonazoid®, 0.01 ml/kg) in six healthy beagles before and after intravenous injection of a combination of butorphanol (0.2 mg/kg) and midazolam (0.1 mg/kg). Furthermore, hemodynamic parameters including blood pressure and heart rate were recorded during the procedure. Five CEUS derived perfusion parameters including time-to-peak (TTP), peak intensity (PI), area under the curve (AUC), wash-in and wash-out rates (WiR and WoR, respectively) before and after sedation were statistically compared. The result showed that no significant change was detected in any of perfusion parameters. Systolic and mean arterial pressures significantly reduced after sedative administration, but diastolic arterial pressure and heart rate did not significantly change. Moreover, no significant partial correlation was observed between perfusion parameters and hemodynamic parameters. Thus, we concluded that the combination did not cause significant influence in duodenal CEUS perfusion parameters and could be a good option for sedation prior to duodenal CEUS in debilitated dogs.
    Matched MeSH terms: Midazolam/adverse effects
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