Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Peking University

Status and phase: Completed; Phase 4

Conditions: Sedation Complication; Fentanyl; Ketamine

Treatments: Drug: Fentanyl; Drug: Midazolam; Drug: Esketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT04597320

PKUSSIRB-202056103

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

Fentanyl group

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl

Drug: Midazolam

Esketamine group

Experimental group

Description:

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.

Treatment:

Drug: Midazolam

Drug: Esketamine