Comparison of Oral and Intranasal Midazolam Premedication in Children Undergoing Cleft Lip and Palate Surgery: A Randomized Controlled Trial.

INTRODUCTION

Preoperative anxiety in pediatric patients undergoing surgery may result in postoperative maladaptive behaviors and prolonged recovery. Midazolam is a commonly used premedication for anxiety reduction. However, the optimal administration route remains unclear, particularly in patients requiring repeated surgeries, such as those with cleft lip and/or palate.

METHODS

We conducted a prospective, randomized controlled trial including 68 pediatric patients aged 1-10 years scheduled for cleft lip and/or palate surgery. The patients were randomly assigned to receive midazolam either orally (0.5 mg/kg in grape juice) or intranasally (0.3 mg/kg via spray). The primary endpoints were emotional reaction during drug administration (Facial Hedonic Score) and ease of administration (Ease of Administration Score). The secondary outcomes included sedation score, ease of parental separation, mask acceptance, and safety parameters. Statistical analysis was conducted using the Mann-Whitney U test with a significance level of p < 0.05.

RESULTS

The oral administration group exhibited significantly lower Facial Hedonic Scores than the intranasal group, suggesting less emotional distress (p = 0.002). No significant differences in ease of administration, sedation depth, parental separation, or mask acceptance were observed between the groups. Furthermore, no adverse events, including respiratory depression and laboratory abnormalities, occurred in either group.

CONCLUSION

Midazolam oral administration is associated with enhanced emotional tolerance in pediatric patients undergoing cleft-related surgeries compared with intranasal administration, with similar efficacy and safety profiles. This route may be preferable in younger or anxious children to minimize preoperative stress.