Behavior ProblemPhase 4NCT06579937
Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy
A Phase 4 study testing Esketamine hydrochloride and normal saline in people with Behavior Problem, run by Fujian Provincial Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Behavior Problem
- What is being tested?
- Esketamine hydrochloride and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to 30 Oct 2025
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
Who cannot join
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index > 30 kg/m2;
- Allergy to study drugs;
- Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- Any other conditions that precluded study inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
Yusheng Yao, MD&PhD
Sisi Chen, MD, 15080109541, chensisi49@163.com
About this study
Official title: Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.
Read more
Participants will:
Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
Read the detailed description
Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.
Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.
- Conditions
- Behavior Problem
- Being tested
- Esketamine hydrochloride, normal saline
- Keywords
- esketamine, postoperative negative behavioral change, pediatrics, emergence delirium, tonsillectomy, adenoidectomy
- Medical subject headings
- Mental Disorders, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine hydrochlorideDrug
Also called esketamine hydrochloride injection
During anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously.
normal salineDrug
During anesthesia induction, a bolus of equal 0.9% saline was administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Esketamine group | Experimental | During anesthesia induction, 0.2 mg/kg esketamine was administered intravenously. Receives: Drug: Esketamine hydrochloride |
| Control group | Placebo comparator | During anesthesia induction, an equal volume of 0.9% saline was administered intravenously. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative day 7
Secondary outcomes (9)
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative day 1
Incidence of emergence delirium
Emergence delirium was assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).
Measured: Within 30 minutes after extubation
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative day 30
Postoperative pain intensity
Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability scale.
Measured: Within 30 minutes after extubation
Preoperative anxiety
Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety.
Measured: Before the intervention in holding area
Emergence time
Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command.
Measured: About up to 30 minutes postoperatively
Parental satisfaction
Parental satisfaction is self-reported using a five-point Likert scale (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, and 1=very dissatisfied).
Measured: Postoperative day 1
Length of postanesthesia care unit stay
Length of postanesthesia care unit (PACU) stay is defined as the time between arrival in the PACU and readiness for discharge from the PACU (defined as a modified Aldrete score of ≥9).
Measured: Up to 60 minutes postoperatively
Incidence of adverse events
Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start2 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yusheng, Fujian Provincial Hospital
- Investigators
- Xiaochun Zheng, MD, Study chair, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579937
- Sponsor's protocol ID
- K2023-02-005
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and/or Adenoidectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06579937
- Acronym / sponsor ID
- K2023-02-005
- Conditions
- Behavior Problem
- Keywords
- esketamine, postoperative negative behavioral change, pediatrics, emergence delirium, tonsillectomy, adenoidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 30 Aug 2024 (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.
The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:
Dose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
Receive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30
Detailed description
Approximately half of children who undergo general anesthesia experience emergence delirium (ED) and postoperative negative behavioral changes (PNBC). There was a positive correlation between delirium during recovery and the change in negative behaviour after the operation.
Esketamine has sedative, analgesic and anti-traumatic stress effects. Based on literature analysis and preliminary trials, this study suggests that intraoperative use of low-dose esketamine may reduce the incidence of emergence delirium and postoperative negative behavior changes in children.
This prospective randomized controlled trial was conducted to compare the effect of intravenous esketamine in the incidence of emergence delirium and postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug) to provide a reference for optimizing clinical anesthesia medication regimens.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esketamine group | Experimental | Drug: Esketamine hydrochlorideDuring anesthesia induction, 0.2 mg/kg esketamine was administered intravenously. |
| Control group | Placebo comparator | Drug: normal salineDuring anesthesia induction, an equal volume of 0.9% saline was administered intravenously. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American society of Aneshesiologists physical status I or II;
- Aged 3-7 years;
- Scheduled for elective tonsillectomy and (or) adenoidectomy.
Key exclusion criteria (8 listed)
- Parents refusing to allow their children to participate;
- Intake of sedative or analgesic medication within 48 hours before surgery;
- Developmental delay;
- Psychosis;
- Body mass index > 30 kg/m2;
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 |
|---|---|---|
| Esketamine hydrochlorideAlso: esketamine hydrochloride injectionDuring anesthesia induction, a 0.2 mg/kg esketamine bolus was administered intravenously. | Drug | Esketamine group |
| normal salineDuring anesthesia induction, a bolus of equal 0.9% saline was administered intravenously. | Drug | Control group |
Primary outcome
Incidence of postoperative negative behavior changes
Time frame: Postoperative day 7
Postoperative negative behavior changes were assessed with Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
9 secondary outcomes
Incidence of postoperative negative behavior changes
Time frame: Postoperative day 1
Incidence of emergence delirium
Time frame: Within 30 minutes after extubation
Incidence of postoperative negative behavior changes
Time frame: Postoperative day 30
Postoperative pain intensity
Time frame: Within 30 minutes after extubation
Preoperative anxiety
Time frame: Before the intervention in holding area
Emergence time
Time frame: About up to 30 minutes postoperatively
Parental satisfaction
Time frame: Postoperative day 1
Length of postanesthesia care unit stay
Time frame: Up to 60 minutes postoperatively
Incidence of adverse events
Time frame: Up to 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes. After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
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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.
Xiaochun Zheng, MD study chair
Fujian Provincial Hospital
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 Esketamine hydrochloride and normal saline in people with Behavior Problem, run by Fujian Provincial Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusheng Yao, MD&PhD (13559939629, fjslyys@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative negative behavior changes (time frame: Postoperative day 7). 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 1 Oct 2024.