Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Phase 4

Completed

• Conditions: Sedation Complication; Fentanyl; Ketamine
• Interventions: Drug: Esketamine; Drug: Fentanyl; Drug: Midazolam

• Registration Number: NCT04597320
• Lead Sponsor: Peking University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2022-01-01
• Primary Completion: 2022-02-28
• Status Verified: 2022-03
• Study Completion: 2022-03-12
• Last Update Submitted: 2022-03-12
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Esketamine group	Esketamine	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.
Fentanyl group	Fentanyl	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.
Fentanyl group	Midazolam	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.
Esketamine group	Midazolam	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.

Primary Outcome Measures

Name	Time	Method
Midazolam use	Day 0	The total use of midazolam
Hypoxemia	Day 0	The incidence of intraoperative hypoxemia (Spo2\<92%)

Secondary Outcome Measures

Name	Time	Method
Successful sedation	Day 0	Success rate of sedation
Agitation and delirium	Day 0	The incidence of agitation and delirium during and after operation
Propofol requiring	Day 0	Incidence of sedation requiring propofol
Recall of intraoperative events	Day 0	The child's recall of intraoperative events
Respiratory depression	Day 0	Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging
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
Circulatory fluctuation	Day 0	Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects
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
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.

Trial Locations

Locations (1)

Peking University Hospital of Stomatology; 🇨🇳 Beijing, Beijing, China