Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Peking University

Status and phase: Completed; Phase 4

Conditions: Dexmedetomidine; Deep Sedation

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04509414

PKUSSIRB-202056077

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. children in need of deep sedation for dental treatment aged 3-7 years.
2. anticipated operation time 1-2hours

Exclusion criteria

1. any known medical records with neural or mental disorder
2. any known medical records with severe systemic disorder
3. history of sedation drug administration in recent 1 months
4. any known allergic history of dexmedetomidine, midazolam or propofol
5. morbid obesity
6. history of OSAHS or acute respiratory infection in 2 weeks
7. other conditions which the attending considers to be unfit for the trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

dexmedetomidine

Experimental group

Description:

2ug/kg intranasal atomized dexmedetomidine

Treatment:

Drug: Dexmedetomidine

midazolam

Active Comparator group

Description:

0.2mg/kg intranasal atomized midazolam

Treatment:

Drug: Midazolam