Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

NCT04597320 | Completed Phase 4

• 1 other identifier: PKUSSIRB-202056103
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The purpose of this study was to investigate and compare the efficacy of esketamine sedation and fentanyl sedation in pediatric dental patients

Conditions

Ketamine; Fentanyl; Sedation Complication

Keywords

Esketamine; Fentanyl; sedation; Pediatric dental patients

Outcome Measures

Primary Outcomes (2)

• Hypoxemia

  The incidence of intraoperative hypoxemia (Spo2\<92%)

  Day 0

• Midazolam use

  The total use of midazolam

  Day 0

Secondary Outcomes (13)

• Successful sedation

  Day 0

• Respiratory depression

  Day 0

• Agitation and delirium

  Day 0

• Circulatory fluctuation

  Day 0

• Propofol requiring

  Day 0

Study Arms (2)

Fentanyl group

ACTIVE COMPARATOR

The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.

Drug: Fentanyl; Drug: Midazolam

Esketamine group

EXPERIMENTAL

The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.

Drug: Esketamine; Drug: Midazolam

Interventions

Fentanyl DRUG

The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".

Fentanyl group

Esketamine DRUG

The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".

Esketamine group

Midazolam DRUG

Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.

Esketamine group; Fentanyl group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-14 years old.
• Oral out-patient sedative treatment in our hospital.
• BMI between 18 to 30 kg/m2. ④. ASA: I-II degree. ⑤. Sign the informed consent.

You may not qualify if:

• Patients who are allergic to esketamine, opioids, propofol, or have contraindications for these drug use.
• Patients with mental illness or who are unable to cooperate.
• Patients who have abnormal reaction to midazolam. ④. Patients who suffer from Apnea. ⑤. Patients who refuse to sign informed consent. ⑥. Patients who participated in other clinical trials within 4 weeks.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Location

MeSH Terms

Interventions

Fentanyl; Esketamine; Midazolam

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Xudong Yang, MD

  Department of anesthesiology of peking university school of stomatology

  STUDY CHAIR

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

Model Details: Fentanyl group and Esketamine group

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 22, 2020
• Study Start: January 1, 2022
• Primary Completion: February 28, 2022
• Study Completion: March 12, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)