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Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

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ClinicalTrials.gov Identifier: NCT04597320
Recruitment Status : Not yet recruiting
First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Yang Xudong, Peking University

Tracking Information
First Submitted Date  ICMJE September 10, 2020
First Posted Date  ICMJE October 22, 2020
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE November 1, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Hypoxemia [ Time Frame: Day 0 ]
    The incidence of intraoperative hypoxemia (Spo2<92%)
  • Midazolam use [ Time Frame: Day 0 ]
    The total use of midazolam
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2020)
  • Successful sedation [ Time Frame: Day 0 ]
    Success rate of sedation
  • Respiratory depression [ Time Frame: Day 0 ]
    Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging
  • Agitation and delirium [ Time Frame: Day 0 ]
    The incidence of agitation and delirium during and after operation
  • Circulatory fluctuation [ Time Frame: Day 0 ]
    Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects
  • Propofol requiring [ Time Frame: Day 0 ]
    Incidence of sedation requiring propofol
  • Time of successful sedation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 0 ]
    Recovery time of directional force
  • Recall of intraoperative events [ Time Frame: Day 0 ]
    The child's recall of intraoperative events
  • Treatment comfort score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients
Official Title  ICMJE The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Fentanyl group and Esketamine group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Ketamine
  • Fentanyl
  • Sedation Complication
Intervention  ICMJE
  • Drug: Fentanyl
    The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Fentanyl
    • Drug: Midazolam
  • 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.
    Interventions:
    • Drug: Esketamine
    • Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xudong Yang, MD 62179977 kqyangxudong@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04597320
Other Study ID Numbers  ICMJE PKUSSIRB-202056103
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Yang Xudong, Peking University
Study Sponsor  ICMJE Peking University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Xudong Yang, MD Department of anesthesiology of peking university school of stomatology
PRS Account Peking University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP