Intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation in pediatric patients undergoing ophthalmic procedures: a randomized controlled trial

Background: Interaction with medical providers is a stressful experience for a child. The current study aimed to assess the efficacy and safety of intranasal midazolam alone versus midazolam/ketamine combination for preoperative sedation prior to ophthalmic procedures in preschool children. This randomized, controlled trial included male and female children (3 to 7 years old) who were American Society of Anesthesiologists (ASA) physical status I or II, with either disability or special needs (such as autism or Down syndrome) or were undergoing multiple operative procedures. Participants were given either intranasal midazolam (0.5 mg/kg) or a combination of intranasal midazolam (0.25 mg/kg) and ketamine (1 mg/kg). Primary outcome measures were the preoperative level of sedation, agitation, and easiness of separation. Secondary outcomes included oxygen saturation and pulse rate. Any adverse effects, such as nausea and vomiting were reported. Results: The mean rank of the Six-point Pediatric Sedation Scale was significantly (p = 0.001) higher in the midazolam/ketamine group compared to the midazolam group (28.15 vs 18.85, respectively). The median pulse rate was significantly (p < 0.001) lower in the midazolam group than the combination group at 5, 10, 15, and 20 min after induction of anesthesia. Conclusions: These findings indicate that intranasal ketamine and midazolam combination produced better sedation than intranasal midazolam alone in preschool children prior to ophthalmic procedures. Moreover, ketamine and midazolam combination was safer with less incidence of bradycardia.