Oral high‐dose midazolam premedication for infants and children undergoing cardiovascular surgery

Masue, Tatsuhiko; Shimonaka, Hiroyuki; Fukao, I; Kasuya, Shugo; Kasuya, Yukiko; Dohi, Shuji

doi:10.1046/j.1460-9592.2003.01119.x

Cited by 19 publications

(9 citation statements)

References 17 publications

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“…According to the available safety data from the studies, higher midazolam doses generally resulted in a higher incidence of adverse events and of cases of over‐sedation (particularly 1‐1.5 mg/kg doses). It has been shown that doses of midazolam higher than 0.5 mg/kg may be associated with increased levels of adverse events such as loss of balance and head control, dysphoria and blurred vision, hypotension, respiratory depression, dysphoric reactions, and ataxia and lead to a higher incidence of deep sedation . Cases of deep sedation with an oral dose of 0.5 mg/kg have also been reported …”

Section: Discussionmentioning

confidence: 99%

“…It has been shown that doses of midazolam higher than 0.5 mg/kg may be associated with increased levels of adverse events such as loss of balance and head control, dysphoria and blurred vision, hypotension, respiratory depression, dysphoric reactions, and ataxia 9,16,18 and lead to a higher incidence of deep sedation. 18,21,23 Cases of deep sedation with an oral dose of 0.5 mg/kg have also been reported. 24 It was noted that some of the adverse events reported are observed when oral midazolam is used in combination with other drugs (following induction of anesthesia, or after administration of treatments used for local anesthesia, or other medications required for the respective interventions) and can therefore not be attributed to midazolam treatment exclusively.…”

Section: Safetymentioning

confidence: 99%

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Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review

Manso

Guittet

Vandenhende³

et al. 2019

Pediatric Anesthesia

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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.

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Section: Discussionmentioning

confidence: 99%

Section: Safetymentioning

confidence: 99%

Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review

Manso

Guittet

Vandenhende³

et al. 2019

Pediatric Anesthesia

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“…Results are comparable with the present study. There are other studies which used 1 mg/kg [17] and 1.5 mg/kg [29] of oral midazolam and found that the children were better sedated than with the standard dose (0.5 mg/kg) of midazolam.…”

Section: Discussionmentioning

confidence: 99%

Midazolam Syrup as a Premedication in Paediatric Patients- A Randomised, Doubleblind, Parallel Group, Placebo-Controlled Study

Bp¹,

D²,

Ct³

2018

jemds

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BACKGROUND Premedication is expedient in reducing the psychological trauma from recalling the unpleasant pre-anaesthetic phases; hence, inducing a trouble-free anaesthesia. Aim-This study was done to evaluate commercially available midazolam syrup 0.25 mg/kg as a premedication in children with regard to sedation, anxiolysis and parental separation score. MATERIALS AND METHODS After IRB approval and written informed consent from parents, this study was conducted in 100 children (ASA I and II), aged 1 to 6 years who were scheduled for various elective and emergency surgeries. Patients were randomly divided into two groups (n= 50 each). Group A was control and Group B received midazolam syrup 0.25 mg/kg 45 minutes before surgery. RESULTS The acceptance of drug was very good. All children in Group A (without premedication) were extremely anxious and crying or thrashing, while in Group B 98% patients were calm and sleepy and separated happily from parents after 45 minutes. Midazolam did not impact the overall recovery time in children. None of the patients in either group developed any complication. CONCLUSION A dose of 0.25 mg/kg of commercially available midazolam syrup offers effective sedation and better emotional control facilitating better separation from parents.

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“…With a success rate of 96%, our results favorably compare with the results reported with other techniques. Indeed, since the introduction of modern imaging (CT and MRI), radiologists and pediatricians have attempted to determine the most effective and safest sedation strategy [14][15][16][17], barbiturates (pentobarbital [5,11,18], methohexital [19][20][21] or thiopental [22][23][24]) and a number of other compounds like chloral hydrate [6,18,25], etomidate [26] and propofol [4,27,28] have been tested (Table 6). With these protocols, sedation has been reported to be effective in 80-100% of patients.…”

Section: Discussionmentioning

confidence: 99%

Deep sedation in pediatric imaging: efficacy and safety of intravenous chlorpromazine

et al. 2012

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Oral high‐dose midazolam premedication for infants and children undergoing cardiovascular surgery

Abstract: Oral midazolam 1.5 mg x kg(-1) is excellent for preanaesthetic medication for infants and children undergoing cardiovascular surgery.

Cited by 19 publications

References 17 publications

Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review

Efficacy of oral midazolam for minimal and moderate sedation in pediatric patients: A systematic review

Midazolam Syrup as a Premedication in Paediatric Patients- A Randomised, Doubleblind, Parallel Group, Placebo-Controlled Study

Deep sedation in pediatric imaging: efficacy and safety of intravenous chlorpromazine

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