Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Study Overview
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Brief Summary
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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

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

Conditions
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Ketamine, Fentanyl, Sedation Complication

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Esketamine
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Fentanyl group and Esketamine group
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esketamine, Fentanyl, sedation, Pediatric dental patients