KetaminePhase 4NCT04597320
Esketamine Sedation and Fentanyl Sedation in Pediatric Dental Patients
A Phase 4 study testing Fentanyl, Esketamine and Midazolam in people with Ketamine and Fentanyl, run by Peking University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Ketamine, Fentanyl, Sedation Complication
- What is being tested?
- Fentanyl, Esketamine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 12 Mar 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Peking University Hospital of Stomatology
Beijing, Beijing Municipality, 100081
About this study
Official title: The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
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
- Conditions
- Ketamine, Fentanyl, Sedation Complication
- Keywords
- Esketamine, Fentanyl, sedation, Pediatric dental patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
EsketamineDrug
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer".
MidazolamDrug
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 group | Role | What they receive |
|---|---|---|
| Fentanyl group | Active comparator | 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. Receives: Drug: Fentanyl; Drug: Midazolam |
| Esketamine group | Experimental | 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. Receives: Drug: Esketamine; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoxemia
The incidence of intraoperative hypoxemia (Spo2<92%)
Measured: Day 0
Midazolam use
The total use of midazolam
Measured: Day 0
Secondary outcomes (13)
Successful sedation
Success rate of sedation
Measured: Day 0
Respiratory depression
Incidence of intraoperative respiratory depression and the need for airway support such as mandibular dragging
Measured: Day 0
Agitation and delirium
The incidence of agitation and delirium during and after operation
Measured: Day 0
Circulatory fluctuation
Occurrence of hypertension, hypotension, bradycardia, tachycardia and other side effects
Measured: Day 0
Propofol requiring
Incidence of sedation requiring propofol
Measured: Day 0
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
Measured: Day 0
MOAA/S score in recovery room
MOAA/S score of patients every 15 minutes after entering the recovery room
Measured: Day 0
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.
Measured: Day 0
Directional force recovery time
Recovery time of directional force
Measured: Day 0
Recall of intraoperative events
The child's recall of intraoperative events
Measured: Day 0
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.
Measured: Day 0
The incidence of complications
The incidence of patients suffered from pain, drowsiness, vomiting, nausea, mental emotion,within 1 day after treatment
Measured: Day 1
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jan 2022
- Primary completion28 Feb 2022
- Study completion12 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetamineStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fentanyl group and Esketamine group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Xudong, Peking University
- Investigators
- Xudong Yang, MD, Study chair, Department of anesthesiology of peking university school of stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597320
- Sponsor's protocol ID
- PKUSSIRB-202056103
- Status last verified
- Mar 2022
- First submitted
- 10 Sep 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04597320
- Acronym / sponsor ID
- PKUSSIRB-202056103
- Conditions
- Ketamine, Fentanyl, Sedation Complication
- Keywords
- Esketamine, Fentanyl, sedation, Pediatric dental patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 12 Mar 2022 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Fentanyl group and Esketamine group
| Arm | Type | Receives |
|---|---|---|
| Fentanyl group | Active comparator | Drug: Fentanyl, Drug: MidazolamThe 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. |
| Esketamine group | Experimental | Drug: Esketamine, Drug: MidazolamThe 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. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-14 years old.
Key exclusion criteria (3 listed)
- Patients who are allergic to esketamine, opioids, propofol, or have contraindications for these drug use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylThe fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". | Drug | Fentanyl group |
| EsketamineThe esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". | Drug | Esketamine group |
| MidazolamMidazolam 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. | Drug | Esketamine group, Fentanyl group |
Primary outcome
Hypoxemia
Time frame: Day 0
The incidence of intraoperative hypoxemia (Spo2<92%)
Midazolam use
Time frame: Day 0
The total use of midazolam
13 secondary outcomes
Successful sedation
Time frame: Day 0
Respiratory depression
Time frame: Day 0
Agitation and delirium
Time frame: Day 0
Circulatory fluctuation
Time frame: Day 0
Propofol requiring
Time frame: Day 0
Time of successful sedation
Time frame: Day 0
MOAA/S score in recovery room
Time frame: Day 0
The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4
Time frame: Day 0
Directional force recovery time
Time frame: Day 0
Recall of intraoperative events
Time frame: Day 0
Treatment comfort score
Time frame: Day 0
The incidence of complications
Time frame: Day 1
Visual Analogue Scale(VAS) of pain in recovery room
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xudong Yang, MD study chair
Department of anesthesiology of peking university school of stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl, Esketamine and Midazolam in people with Ketamine and Fentanyl, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoxemia (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.