Nebulization of a combination of low dose dexmedetomidine and ketamine versus dexmedetomidine alone as a premedication for children undergoing cleft palate repair surgeries: A prospective randomized clinical trial

Abstract

Background

Sedation for young children who have cleft palate is challenging as poorly titrated sedation may result in respiratory depression, airway obstruction, or desaturation. The aim of this trial was to evaluate whether a nebulized combination of ketamine and low dose dexmedetomidine provides more effective preoperative sedation than dexmedetomidine alone in a higher dose for children undergoing cleft palate repair surgeries.

Methods

Fifty-six children, aged 1-4 years, who underwent cleft palate repair surgeries under general anesthesia were randomly assigned to receive preoperative sedation via nebulization either with a mixture of dexmedetomidine (1 µg/kg) and ketamine (2 mg/kg) in group DK (n = 28) or dexmedetomidine (2 µg/kg) alone in group D (n = 28). The primary outcome was the level of sedation after 30 minutes of completion of the nebulization. The secondary outcomes included assessment of parental separation, anesthesia mask acceptance, postoperative emergence delirium, postoperative pain, and any adverse events.

Results

The median (Q1-Q3) University of Michigan Sedation Scale score after 30 minutes of completion of the nebulization was 2 (1.3-2) in group DK versus 1 (1-2) in group D (P = 0.013). Furthermore, group DK showed more accepted parental separation anxiety scores and more satisfactory mask acceptance scores than group D (P = 0.005 and 0.018 respectively).

Conclusions

As a premedication for children undergoing cleft palate repair surgeries, a nebulized combination of ketamine and low dose dexmedetomidine appeared to be more effective than dexmedetomidine alone in a higher dose. This combination was also associated with better parental separation and acceptance of the anesthesia mask.