Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

Dexmedetomidine Clinical Trial

Official title:

Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04509414
• Other study ID #: PKUSSIRB-202056077
• Status: Completed
• Phase: Phase 4
• Start date: April 10, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Sedation
• Dexmedetomidine

Intervention

Drug:
• Dexmedetomidine
For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
• Midazolam
For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	peri-operative satisfaction	satisfaction of surgeon and parents during the whole clinical treatment and follow-up, they will be asked to give a score from 1 to 10, 10 stands for completely satisfied and 1 stands for not satisfied at all	up to 24 hours
Other	post-operative condition of the child	complications and behavior changes assessed with Post-Hospitalization Behavior Questionnaire(PHBQ)	up to 24 hours
Primary	venipuncture acceptance	acceptance while starting the IV line, at most 2 tries	Day 0
Secondary	Observer's Assessment of Alertness/Sedation(MOAA/S) Score	sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)	Day 0
Secondary	remedial mask induction acceptance	acceptance of the mask induction(for those failed to start the IV before induction)	Day 0
Secondary	propofol dosage	the total dosage of propofol used from induction till the end of the clinical treatment	Day 0
Secondary	patients' discomfort	any adverse reaction or discomfort complaints of patients will be recorded, such as sneeze, blocked nose, bitter taste, dizziness, rhinalgia, etc.	up to 24 hours
Secondary	hypoxemia	decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)	Day 0
Secondary	peri-operative blood pressure	peri-operative blood pressure states	Day 0
Secondary	peri-operative heart rate	peri-operative heart rate	Day 0
Secondary	times of intra-operative airway assistance	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.	Day 0
Secondary	post-operative pain	pain assessment with modified children's hospital of eastern Ontario pain score(m-CHEOPS) from the end of dental procedure till discharge	Day 0
Secondary	post-operative agitation	emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge	Day 0
Secondary	discharge time	time from the end of dental procedure till discharge	Day 0