Efficacy of intranasal administration of dexmedetomidine in combination with midazolam for sedation in infant with cleft lip and palate: A double blinded prospective randomized trial

Objectives: This study aimed to evaluate the efficacy of intranasal administration of dexmedetomidine combined with midazolam as a sedative option for infants with cleft lip and palate. Materials: and Methods Infants scheduled for cleft lip and palate repair surgery were randomly assigned to the IND group (intranasal dexmedetomidine 2 µg/kg alone) and the INDM group (intranasal dexmedetomidine 2 µg/kg combined with midazolam 0.05 mg/kg). The primary outcome was the proportion of infants underwent successful computed tomography scans under intranasal sedation. The secondary outcomes included onset time and duration of sedation, recovery time and so on. Results: 105 infants were included in the analysis. The proportion of infants underwent successful CT scans under sedation was significantly greater in the INDM group than in the IND group (47 [95.9%] vs. 45 [80.4%], p  = 0.016). Additionally, the INDM group had a shorter onset time and a longer duration of sedation statistically (12 [8.5, 17] min vs. 16 [12, 20] min, p  = 0.001; 80 [63.6, 92.5] min vs. 68.5 [38, 89] min, p  = 0.014, respectively), and their recovery time was significantly longer (43 [30, 59.5] min vs. 31.5 [20.5, 53.5] min, p  = 0.006). Conclusion: Intranasal administration of dexmedetomidine combined with midazolam resulted in higher sedation success in comparison with sole dexmedetomidine. Clinical Relevance: Intranasal administration of dexmedetomidine combined with midazolam can be used for sedation in infants with cleft lip and palate imaging procedure and provide a faster onset time. Clinical Trial Registration site: https://www.chictr.org.cn. Clinical Trial Registration number: ChiCTR2100049122.