Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients
NCT ID: NCT04597320
Last Updated: 2022-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2022-01-01
2022-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Fentanyl
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
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.
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.
Esketamine
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
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.
Interventions
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Fentanyl
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
Esketamine
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
14 Years
ALL
No
Sponsors
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Peking University
OTHER
Responsible Party
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Yang Xudong
Chief of Department of Anesthesiology
Principal Investigators
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Xudong Yang, MD
Role: STUDY_CHAIR
Department of anesthesiology of peking university school of stomatology
Locations
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Peking University Hospital of Stomatology
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PKUSSIRB-202056103
Identifier Type: -
Identifier Source: org_study_id
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