Comparison of the efficacy of intranasal atomised dexmedetomidine versus intranasal atomised ketamine as a premedication for sedation and anxiolysis in children undergoing spinal dysraphism surgery: A randomized controlled trial.

BACKGROUND: Preoperative anxiety leads to adverse clinical outcomes and long-term maladaptive behavioural changes. The role of intranasal atomised dexmedetomidine and atomised ketamine as premedication to produce sedation and anxiolysis in paediatric neurosurgical patients has not been extensively studied.

OBJECTIVE: To study the efficacy of intranasal atomised dexmedetomidine and intranasal atomised ketamine as premedication in producing sedation and facilitating smooth induction in children undergoing spinal dysraphism surgery.

DESIGN: A prospective randomised double-blind trial.

SETTING: A tertiary teaching hospital.

PATIENTS: Sixty-four children aged 1 to 10 years undergoing spinal dysraphism surgery.

METHODS: Children were randomised to receive intranasal atomised dexmedetomidine 2.5 μg kg-1 (Group D, n = 32) and intranasal atomised ketamine 5 mg kg-1 (Group K, n = 32) 30 min before surgery.

OUTCOMES MEASURED: The primary outcome was to compare the level of sedation in both groups using the University of Michigan Sedation Score (UMSS). The secondary outcomes included an assessment of the ease of parental separation, intravenous cannulation and satisfactory mask acceptance along with perioperative vitals (Heart rate, blood pressure and oxygen saturation). The incidence of emergence agitation and time to discharge were also noted.

RESULTS: The degree of sedation was significantly better in Group D as compared to Group K at 20 min (UMSS, 1.55 ± 0.51 versus 1.13 ± 0.34, difference, -0.406; 95% CI, -0.621 to -0.191; P = 0.0001) and 30 min (2.32 ± 0.6 versus 1.94 ± 0.50, difference, -0.374; 95% CI, -0.650 to 0.100; P = 0.007). The ease of parental separation, venous cannulation and mask acceptance (P = 0.83, 0.418 and 0.100 respectively) were comparable in both groups. The heart rate was lower in group D at 10, 20 and 30 min post-drug administration but was clinically insignificant. The incidence of emergence agitation and time to discharge was also similar with no adverse events reported.

CONCLUSION: Intranasal atomised dexmedetomidine produces greater sedation as compared to intranasal atomised ketamine with comparable ease of parental separation, venous cannulation and mask acceptance with no adverse effects.