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Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

NCT04509414 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-10
Primary Completion
2022-05-01
Completion
2022-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04509414 on ClinicalTrials.gov