Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Phase 4

Completed

• Conditions: Deep Sedation; Dexmedetomidine
• Interventions: Drug: Midazolam; Drug: Dexmedetomidine

• Registration Number: NCT04509414
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-10
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-08-08
• Study First Posted: 2020-08-12
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-09
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam	Midazolam	0.2mg/kg intranasal atomized midazolam
dexmedetomidine	Dexmedetomidine	2ug/kg intranasal atomized dexmedetomidine

Primary Outcome Measures

Name	Time	Method
venipuncture acceptance	Day 0	acceptance while starting the IV line, at most 2 tries

Secondary Outcome Measures

Name	Time	Method
hypoxemia	Day 0	decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)
post-operative agitation	Day 0	emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge
discharge time	Day 0	time from the end of dental procedure till discharge
times of intra-operative airway assistance	Day 0	Any intra-operative airway assistance in need which aims to improve ventilation will be recorded, including jaw lifting, suction, mask ventilation and intubation. Specific type of assistance will also be recorded in detail.
post-operative pain	Day 0	pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge
remedial mask induction acceptance	Day 0	acceptance of the mask induction（for those failed to start the IV before induction）
propofol dosage	Day 0	the total dosage of propofol used from induction till the end of the clinical treatment
peri-operative blood pressure	Day 0	peri-operative blood pressure states
peri-operative heart rate	Day 0	peri-operative heart rate
Observer's Assessment of Alertness/Sedation(MOAA/S) Score	Day 0	sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)
patients' discomfort	up to 24 hours	any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc.

Trial Locations

Locations (1)

Peking University Hospital of Stomatology; 🇨🇳 Beijing, Beijing, China