Background: Premedication is widely used in pediatric anesthesia to reduce emotional trauma and ensure smooth induction. The rectal route is one of the most commonly accepted means of drug administration. The aim of our study was to investigate and compare the efficacy of rectally administered midazolam versus that of ketamine as a premedication in pediatric patients.

Methods: We performed a prospective randomized double-blinded clinical trial in 64 children, 1 to 10 years of age, randomly allocated into two groups. The midazolam group received 0.5 mg/kg rectal midazolam and the ketamine group received 5 mg/kg rectal ketamine. The preoperative sedation scores were evaluated on a three-point scale. The anxiolysis and mask acceptance scores were evaluated separately on a four-point scale, with ease of parental separation, based on the presence or lack of crying, evaluated on a two-point scale.

Results: Neither medication showed acceptable sedation (>75%), with no significant difference in sedation score between the two groups (P=0.725). Anxiolysis and mask acceptance using either midazolam or ketamine were acceptable, with  midazolam performing significantly better than ketamine (P=0.00 and P=0.042, respectively). Ease of parental separation was seen in both groups without significant difference (P=0.288) and no major adverse effects, such as apnea, occurred in either group.

Conclusions: Rectal midazolam is more effective than ketamine in anxiolysis and mask acceptance. Although they both can ease separation anxiety in children before surgery, we found neither drug to be acceptable for sedation.