Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Sponsor

Peking University (Other)

Overall Status

Completed

CT.gov ID

NCT04597320

Collaborator

(none)

Enrollment

Location

Arms

2.3

Actual Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ketamine Fentanyl Sedation Complication	Drug: Fentanyl Drug: Esketamine Drug: Midazolam	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Fentanyl group and Esketamine groupFentanyl group and Esketamine group

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Feb 28, 2022

Actual Study Completion Date :

Mar 12, 2022

Arms and Interventions

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: Esketamine The esketamine group was prepared by 0.5mg/kg esketamine 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.

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: Esketamine

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

Drug: Midazolam

Outcome Measures

Primary Outcome Measures

Hypoxemia [Day 0]
The incidence of intraoperative hypoxemia (Spo2<92%)
Midazolam use [Day 0]
The total use of midazolam

Secondary Outcome Measures

Successful sedation [Day 0]
Success rate of sedation
Respiratory depression [Day 0]
Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging
Agitation and delirium [Day 0]
The incidence of agitation and delirium during and after operation
Circulatory fluctuation [Day 0]
Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects
Propofol requiring [Day 0]
Incidence of sedation requiring propofol
Time of successful sedation [Day 0]
The time when the MOAA/S score was equal to 3 points for the first time after patients were given anesthetic inducer
MOAA/S score in recovery room [Day 0]
MOAA/S score of patients every 15 minutes after entering the recovery room
The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4 [Day 0]
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.
Directional force recovery time [Day 0]
Recovery time of directional force
Recall of intraoperative events [Day 0]
The child's recall of intraoperative events
Treatment comfort score [Day 0]
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.
The incidence of complications [Day 1]
The incidence of patients suffered from pain, drowsiness, vomiting, nausea, mental emotion,within 1 day after treatment
Visual Analogue Scale(VAS) of pain in recovery room [Day 0]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.