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NCT Number: NCT04597320

Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

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

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Key information

Conditions

Ketamine Fentanyl Sedation Complication

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking University Hospital of Stomatology

Beijing, Beijing Municipality, 100081, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

Drug

The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".

Esketamine

Drug

The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".

midazolam

Drug

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 outcomes

  1. Hypoxemia

    Time frame: Day 0

    The incidence of intraoperative hypoxemia (Spo2<92%)

  2. Midazolam use

    Time frame: Day 0

    The total use of midazolam

Secondary outcomes

  1. Successful sedation

    Time frame: Day 0

    Success rate of sedation

  2. Respiratory depression

    Time frame: Day 0

    Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging

  3. Agitation and delirium

    Time frame: Day 0

    The incidence of agitation and delirium during and after operation

  4. Circulatory fluctuation

    Time frame: Day 0

    Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects

  5. Propofol requiring

    Time frame: Day 0

    Incidence of sedation requiring propofol

  6. 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

  7. MOAA/S score in recovery room

    Time frame: Day 0

    MOAA/S score of patients every 15 minutes after entering the recovery room

  8. 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.

  9. Directional force recovery time

    Time frame: Day 0

    Recovery time of directional force

  10. Recall of intraoperative events

    Time frame: Day 0

    The child's recall of intraoperative events

  11. 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.

  12. 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

  13. 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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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