drugset / Trial / NCT05925283

Clinical Study of Oral Midazolam Combined With Esketamine Administered Intranasally for Pediatric Preoperative Sedation

NCT05925283

RandomizedParallel-groupDouble-blindTreatment

Summary

Children are prone to anxiety and even fear before surgery, and such adverse emotions may not only lead to poor induction of anesthesia, but also increase the incidence of postoperative agitation and even lead to postoperative behavioral changes in children. There are many ways to relieve pediatric anxiety, including preoperative medication, games, and cartoons. Preoperative medication is the most commonly used method to relieve pediatric anxiety.The most commonly used pediatric preoperative sedation drugs are midazolam and esketamine.However, oral midazolam may not produce a sedative effect in 20-40% of patients. A good preoperative anxiety-reducing effect was seen in only 60-80% of cases.Therefore, this trial investigates whether the intranasal combination of esketamine with oral midazolam can produce better results than each of the two drugs alone. This will provide a reference for the selection of safe, reliable and appropriate preoperative sedation methods for pediatric patients and provide evidence-based support for comfort care.

Timeline

Start
2023-06-30
Primary completion
2023-11-30
Completion
2024-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.6 mg/kg Intranasal
Subject Esketamine Other / unclassified 1 mg/kg Intranasal
Comparator Midazolam Small molecule 0.3 mg/kg Oral
Comparator Midazolam Small molecule 0.5 mg/kg Oral

Indications