Fentanyl, Ketamine, Sedation Complication
Conditions
Keywords
Esketamine, Fentanyl, sedation, Pediatric dental patients
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
Interventions
DRUGFentanyl
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as Anesthesia inducer.
DRUGEsketamine
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as Anesthesia inducer.
DRUGMidazolam
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.
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Fentanyl group and Esketamine group
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoxemia | Day 0 | The incidence of intraoperative hypoxemia (Spo2\<92%) |
| Midazolam use | Day 0 | The total use of midazolam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agitation and delirium | Day 0 | The incidence of agitation and delirium during and after operation |
| Circulatory fluctuation | Day 0 | Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects |
| Propofol requiring | Day 0 | Incidence of sedation requiring propofol |
| Time of successful sedation | 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 | Day 0 | MOAA/S score of patients every 15 minutes after entering the recovery room |
| Successful sedation | Day 0 | Success rate of sedation |
| Directional force recovery time | Day 0 | Recovery time of directional force |
| Recall of intraoperative events | Day 0 | The child's recall of intraoperative events |
| Treatment comfort score | 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 | 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 | 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. |
| The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4 | 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. |
| Respiratory depression | Day 0 | Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging |
Countries
China
Outcome results
None listed