Dexmedetomidine-Ketamine or Dexmedetomidine-Midazolam Nebulised Drug Combination as a Premedicant in Children: A Randomised Clinical Trial

Objective: This study was designed to evaluate the clinical efficacy of 2 low-dose nebulised drug combinations of dexmedetomidine-ketamine and dexmedetomidine-midazolam as a premedication in children scheduled for surgery under general anaesthesia. Methods: Sixty children classified as American Society of Anesthesiologists physical status I, aged between 3 and 10, listed to undergo elective surgeries under general anaesthesia were enrolled in this prospective, randomised, and double-blind trial. Patients were randomly allocated to receive nebulised premedication approximately 30 minutes before the induction of anaesthesia. Group DK (n = 30) received combined nebulised dexmedetomidine and ketamine (1 mu g kg(-1) + 1 mg kg(-1)) and the dexmedetomidine-midazolam (DM) group (n = 30) received combined nebulised dexmedetomidine and midazolam (1 mu g kg(-1) + 0.1 mg kg(-1)). All children were anaesthetised with a protocolised anaesthesia technique. The primary end point was the level of sedation when the child was first seen in the operating room 30 minutes after nebulisation. The secondary end points were parental separation and ease of induction, ease of acceptance of IV cannula, mask acceptance, postoperative analgesia, and wake-up behaviour. Results: Studied groups were comparable in demographic data (age, weight, and sex) and duration of anaesthesia. Level of sedation at 30 minutes was significantly greater in the DM group than in the DK group (P =.013) while the two were comparable in parental separation and ease of induction (P =.808). Group DK exhibited superior ease of acceptance of IV cannula (P =.001), mask acceptance score (P =.001), and postoperative analgesia (P =.021). Hemodynamic parameters and oxygen saturation remained comparable at all time intervals as also the wake-up behaviour. Conclusions: The nebulised combination of low-dose ketamine and dexmedetomidine was a superior combination producing acceptable sedation with enhanced ease of IV acceptance, mask acceptance, and postoperative analgesia in children.