Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients

Sedation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597320
• Other study ID #: PKUSSIRB-202056103
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: March 12, 2022

Study information

• Verified date: March 2022
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 12, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

Inclusion Criteria:

• Age 6-14 years old.
• Oral out-patient sedative treatment in our hospital.
• BMI between 18 to 30 kg/m2. ?. ASA: I-II degree. ?. 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. ?. Patients who suffer from Apnea. ?. Patients who refuse to sign informed consent. ?. Patients who participated in other clinical trials within 4 weeks.

Related Conditions & MeSH terms

• Fentanyl
• Ketamine
• Sedation Complication

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking University Hospital of Stomatology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoxemia	The incidence of intraoperative hypoxemia (Spo2<92%)	Day 0
Primary	Midazolam use	The total use of midazolam	Day 0
Secondary	Successful sedation	Success rate of sedation	Day 0
Secondary	Respiratory depression	Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging	Day 0
Secondary	Agitation and delirium	The incidence of agitation and delirium during and after operation	Day 0
Secondary	Circulatory fluctuation	Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects	Day 0
Secondary	Propofol requiring	Incidence of sedation requiring propofol	Day 0
Secondary	Time of successful sedation	The time when the MOAA/S score was equal to 3 points for the first time after patients were given anesthetic inducer	Day 0
Secondary	MOAA/S score in recovery room	MOAA/S score of patients every 15 minutes after entering the recovery room	Day 0
Secondary	The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4	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.	Day 0
Secondary	Directional force recovery time	Recovery time of directional force	Day 0
Secondary	Recall of intraoperative events	The child's recall of intraoperative events	Day 0
Secondary	Treatment comfort score	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.	Day 0
Secondary	The incidence of complications	The incidence of patients suffered from pain, drowsiness, vomiting, nausea, mental emotion,within 1 day after treatment	Day 1
Secondary	Visual Analogue Scale(VAS) of pain in recovery room	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.	Day 0