Intranasal Dexmedetomidine for Deep-sedated Pediatric Dental Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Deep Sedation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100081
      • Peking University Hospital of stomatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: dexmedetomidine; 2ug/kg intranasal atomized dexmedetomidine	Drug: Dexmedetomidine; For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
ACTIVE_COMPARATOR: midazolam; 0.2mg/kg intranasal atomized midazolam	Drug: Midazolam; For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
venipuncture acceptance	acceptance while starting the IV line, at most 2 tries	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observer's Assessment of Alertness/Sedation(MOAA/S) Score	sedation scoring with MOAA/S scale(from intranasal drug administration till discharge)	Day 0
remedial mask induction acceptance	acceptance of the mask induction（for those failed to start the IV before induction）	Day 0
propofol dosage	the total dosage of propofol used from induction till the end of the clinical treatment	Day 0
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
hypoxemia	decreased oxygen saturation up to 90%, and the treatment will also be recorded(if any)	Day 0
peri-operative blood pressure	peri-operative blood pressure states	Day 0
peri-operative heart rate	peri-operative heart rate	Day 0
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
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
post-operative agitation	emergence agitation assessment with Pediatric Anesthesia Emergence Delirium scale(PAED) from the end of dental procedure till discharge	Day 0
discharge time	time from the end of dental procedure till discharge	Day 0

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
post-operative condition of the child	complications and behavior changes assessed with Post-Hospitalization Behavior Questionnaire(PHBQ)	up to 24 hours

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2020
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: August 8, 2020
• First Posted (ACTUAL): August 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: pediatric; dexmedetomidine; deep sedation; dental treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: PKUSSIRB-202056077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No