NCT04597320

Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 6 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The purpose of this study was to investigate and compare the efficacy of esketamine sedation and fentanyl sedation in pediatric dental patients

Conditions

• Ketamine
• Fentanyl
• Sedation Complication

Interventions

Type	Name	Description
DRUG	Fentanyl	The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
DRUG	Esketamine	The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
DRUG	Midazolam	Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-02-28
• Completion: 2022-03-12
• First posted: 2020-10-22
• Last updated: 2022-03-15

Locations

1 site across 1 country: China