Effectiveness and safety of Ketamine and Midazolam mixture for procedural sedation in children with mental disabilities: A randomized study of intranasal versus intramuscular route

Abstract

Background: Sedation outside the operating room is challenging especially for mentally disabled children. The intravenous sedation is an effective way of drug administration, but it is difficult to insert. The intramuscular route still has fear of injection. The intranasal route can be an effective, needleless, and painless approach for procedural sedation. Methods: 40 children with a mental disability aged from 4–12 years classified as ASA class I and II were included after parents’ approval for procedural sedation. They were divided into two groups; IN who received intranasal Midazolam 0.2 mg/kg and Ketamine 5 mg/kg and group IM who received the same dose intramuscularly. The heart rate, oxygen saturation and mean arterial blood pressure were recorded. We used the Pediatric Sedation State Scale to assess the level of sedation of children. Also, the satisfaction of the parents and complications were recorded. Results: The onset of sedation showed no statistical difference between the two groups while the duration of sedation and the time of discharge from the post-anesthesia care unit were significantly higher in the IM group. The sedation score was statistically higher in the IM group at 10 minutes while in 20 and 30 minutes it showed no statistically significant difference with comparable sedation state. Parents of IN group showed a statistically significant higher level of satisfaction. Conclusion: Midazolam and Ketamine mixture given through the nasal route with nasal atomization device is a needleless approach and as effective and safe as an intramuscular route for procedural sedation in mentally disabled children.