Manso MA, et al. - Researchers analyzed 25 pediatric clinical studies in this systematic review of the literature to determine whether oral midazolam is an effective option for sedation in pediatric patients in the context of premedication prior to anesthesia or during diagnostic/treatment procedures. Following single administration of oral midazolam, the percentage of responders (response rate) were assessed and were compared vs placebo in a subset of placebo-controlled investigations. Overall 1,472 patients (aged 4 months-18 years) who had received midazolam (0.25-1.5 mg/kg) and 138 treated with placebo were studied. With oral midazolam, the range of the response rates was from 36.7% to 97.8%, this was from 4.0% to 41.0% for placebo response rates. Subgroup analysis revealed that oral midazolam response rates ranged from 36.7% to 97.0% and from 56.1% to 97.8% for anesthetic premedication and for medical procedures, respectively. Findings revealed that a dose of 0.25 mg/kg and above of midazolam was efficacious for pediatric minimal/moderate sedation. With increasing doses, an increase in the likelihood of occurrence of adverse events and over-sedation was observed.