Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2022-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Deep Sedation Dexmedetomidine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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dexmedetomidine

2ug/kg intranasal atomized dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.

midazolam

0.2mg/kg intranasal atomized midazolam

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Interventions

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Dexmedetomidine

For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.

Intervention Type DRUG

Midazolam

For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No