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

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.

Anesthesia, Sedation, and Unplanned Extubation of Tracheal Intubation in Children with Severe Pneumonia

“…Midazolam is currently a commonly used sedative drug for mechanical ventilation in children, but it has many shortcomings. It cannot effectively inhibit the stress response caused by the endotracheal tube, and long-term infusion may cause adverse reactions such as delayed awakening of children, so the sedative effect is poor [ 15 ]. Dexmedetomidine is a highly potent and highly selective α 2 adrenergic receptor agonist [ 16 ].…”

Anxiolytic premedication for children

“…10 Responder rates suggest that smaller doses (0.25e0.5 mg kg À1 depending on the preparation used) of midazolam are almost as effective as higher doses (0.75e1.5 mg kg À1 ) and little advantage is gained by increasing the dose. 11 Midazolam is also associated with an increased incidence of postoperative agitation. a 2 -adrenoceptor agonists Dexmedetomidine is a highly selective a 2 -adrenoceptor agonist that provides anxiolysis and sedation, whilst providing additional benefits, including analgesic effects and avoidance of respiratory depression.…”

Post-Discharge Effects and Parents’ Opinions of Intranasal Fentanyl with Oral Midazolam Sedation in Pediatric Dental Patients: A Cross-Sectional Study

“…Notably, there has been an increased interest in drugs with both sedative and analgesic properties, such as dexmedetomidine, ketamine, and fentanyl [ 17 , 18 ].…”