The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Peking University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Midazolam use
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 6-14 years old.
- •Oral out-patient sedative treatment in our hospital.
- •BMI between 18 to 30 kg/m
- •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.
Arms & Interventions
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.
Intervention: Fentanyl (Drug)
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.
Intervention: Midazolam (Drug)
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.
Intervention: Esketamine (Drug)
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.
Intervention: Midazolam (Drug)
Outcomes
Primary Outcomes
Midazolam use
Time Frame: Day 0
The total use of midazolam
Hypoxemia
Time Frame: Day 0
The incidence of intraoperative hypoxemia (Spo2\<92%)
Secondary Outcomes
- Successful sedation(Day 0)
- Agitation and delirium(Day 0)
- Propofol requiring(Day 0)
- Recall of intraoperative events(Day 0)
- Respiratory depression(Day 0)
- The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4(Day 0)
- Directional force recovery time(Day 0)
- Circulatory fluctuation(Day 0)
- Time of successful sedation(Day 0)
- MOAA/S score in recovery room(Day 0)
- Treatment comfort score(Day 0)
- The incidence of complications(Day 1)
- Visual Analogue Scale(VAS) of pain in recovery room(Day 0)
Investigators
Yang Xudong
Chief of Department of Anesthesiology
Peking University