Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Ketamine; Sedation Complication; Fentanyl
• Intervention / Treatment: Drug: Fentanyl; Drug: Midazolam; Drug: Esketamine

• Study Type: Interventional
• Enrollment (Actual): 48
• 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: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fentanyl group; 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; The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".; Drug: Midazolam; 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.
Experimental: Esketamine group; 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: Midazolam; 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; The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoxemia	The incidence of intraoperative hypoxemia (Spo2<92%)	Day 0
Midazolam use	The total use of midazolam	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful sedation	Success rate of sedation	Day 0
Respiratory depression	Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging	Day 0
Agitation and delirium	The incidence of agitation and delirium during and after operation	Day 0
Circulatory fluctuation	Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects	Day 0
Propofol requiring	Incidence of sedation requiring propofol	Day 0
Time of successful sedation	The time when the MOAA/S score was equal to 3 points for the first time after patients were given anesthetic inducer	Day 0
MOAA/S score in recovery room	MOAA/S score of patients every 15 minutes after entering the recovery room	Day 0
The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4	The time for MOAA/S score to be greater than 4 since the end of clinical operation and the cessation of anesthetic infusion. MOAA/S is from 0 to 5, the higher of the score means the less sedative condition.	Day 0
Directional force recovery time	Recovery time of directional force	Day 0
Recall of intraoperative events	The child's recall of intraoperative events	Day 0
Treatment comfort score	Patients' satisfaction score of treatment comfort. This score is from 0 to 10, the higher of the score means the more comfortable of the treatment patients received.	Day 0
The incidence of complications	The incidence of patients suffered from pain, drowsiness, vomiting, nausea, mental emotion,within 1 day after treatment	Day 1
Visual Analogue Scale(VAS) of pain in recovery room	Evaluate patients' VAS of pain every 15 minutes after entering the recovery room. This scale is from 0 to 10, the higher of the scale means the more painful patients feel.	Day 0

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): March 12, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 12, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fentanyl; sedation; Esketamine; Pediatric dental patients
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; 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, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Fentanyl; Midazolam; Esketamine
• Other Study ID Numbers: PKUSSIRB-202056103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No