Abstract
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.
Highlights
It is estimated that more than 50% of children could benefit from minimal to moderate sedation during perioperative or procedural periods to treat or prevent behavioral stress and anxiety, caused by separation from their families, the presence of an unfamiliar environ‐ ment, or fear of pain.[1-4]The objective of minimal/moderate sedation is to enable the ac‐ complishment of a scheduled intervention with a child who is calm, in order to prevent psychological distress prior to or during the inter‐ vention, to avoid poor compliance or cancelation, and any potential negative impact on postoperative recovery or other possible long‐ term psychological consequences.[4-6]Midazolam has a very long track record of use for minimal and moderate sedation and remains the most commonly used oral sed‐ ative for anxiolysis in children
Among the drugs used for moderate sedation, oral midazolam offers the advantage of being an effica‐ cious, short‐acting benzodiazepine, with anxiolytic, sedative, and hypnotic properties, with a favorable benefit/risk ratio.[8]
Since the late 1980s, a number of clinical trials have been published eval‐ uating the efficacy of oral midazolam for sedation in children; a large volume of information relating to oral midazolam as a sedative in pediatric patients is available
Summary
Midazolam has a very long track record of use for minimal and moderate sedation and remains the most commonly used oral sed‐ ative for anxiolysis in children. Among the drugs used for moderate sedation, oral midazolam offers the advantage of being an effica‐ cious, short‐acting benzodiazepine, with anxiolytic, sedative, and hypnotic properties, with a favorable benefit/risk ratio.[8]. Since the late 1980s, a number of clinical trials have been published eval‐ uating the efficacy of oral midazolam for sedation in children; a large volume of information relating to oral midazolam as a sedative in pediatric patients is available. There is, a broad range of oral doses used in pediatric patients for minimal/ moderate sedation, and the optimum dosing in different contexts of sedation remains unclear
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