NCT04509414

Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery. Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures. This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.

Conditions

• Deep Sedation
• Dexmedetomidine

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
DRUG	Midazolam	For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Timeline

• Start date: 2020-04-10
• Primary completion: 2022-05-01
• Completion: 2022-05-31
• First posted: 2020-08-12
• Last updated: 2023-02-10

Locations

1 site across 1 country: China