Paradoxical reactions to rectal midazolam as premedication in children.

Eighty healthy children, between the ages of 2 and 7 years, who were to undergo oral surgical procedures under general anaesthesia, were allocated randomly to 4 groups. Three groups received rectal midazolam, and the other group a placebo (saline) as premedication 30 min prior to induction of anaesthesia. Group A children received midazolam 0.25 mg/kg, Group B 0.35 mg/kg and Group C 0.45 mg/kg. No statistically significant difference was found between the treatment groups as to the effect on systolic- (p = 0.6920) and diastolic (p = 0.8701) blood pressures, respiration (p = 0.0505) and pulse (p = 0.6192) rates at either pre- or post-sedation levels. However, the results indicate that levels of anxiolysis and sedation were significantly associated with midazolam dosage (p less than 0.0001).

RCT Entities:   Population Interventions Outcomes