Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

NCT04509414 | Completed Phase 4

• 1 other identifier: PKUSSIRB-202056077
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

deep sedation; pediatric; dexmedetomidine; dental treatment

Outcome Measures

Primary Outcomes (1)

• venipuncture acceptance

  acceptance while starting the IV line, at most 2 tries

  Day 0

Secondary Outcomes (11)

• Observer's Assessment of Alertness/Sedation(MOAA/S) Score

  Day 0

• remedial mask induction acceptance

  Day 0

• propofol dosage

  Day 0

• patients' discomfort

  up to 24 hours

• hypoxemia

  Day 0

Other Outcomes (2)

• peri-operative satisfaction

  up to 24 hours

• post-operative condition of the child

  up to 24 hours

Study Arms (2)

dexmedetomidine

EXPERIMENTAL

2ug/kg intranasal atomized dexmedetomidine

Drug: Dexmedetomidine

midazolam

ACTIVE COMPARATOR

0.2mg/kg intranasal atomized midazolam

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

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

dexmedetomidine

Midazolam DRUG

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

midazolam

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

MeSH Terms

Interventions

Dexmedetomidine; Midazolam

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Anesthesiology

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 12, 2020
• Study Start: April 10, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 31, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CN (1)