Behavior ProblemPhase 4PEDI-NPOBCsNCT07570160
Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in Children
A Phase 4 study testing Dexmedetomidine, Esketamine and Normal Saline in people with Behavior Problem, run by Nanjing Children's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Behavior Problem
- What is being tested?
- Dexmedetomidine, Esketamine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2 to 12 years.
- Scheduled to undergo elective day surgery under general anesthesia.
- ASA (American Society of Anesthesiologists) physical status I to III.
Who cannot join
- Congenital diseases or severe liver or kidney dysfunction.
- History of allergic reactions to study drugs.
- Neuromuscular diseases, cerebral palsy, epilepsy.
- Other psychiatric or neurological disorders.
- Body mass index (BMI) ≥ 30 kg/m².
- Severe upper respiratory tract infections prior to surgery.
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- Use of sedatives or analgesics within 48 hours before surgery.
- Exposure to major life stressors within 1 month before surgery (e.g., family separation, death of a parent).
- Refusal to participate or failure to obtain consent from the child's legal guardian.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008
Medical Ethics Committee of Children's Hospital of Nanjing Med, +86 189 5176 2937, drsunfei@njmu.edu.cn
About this study
Official title: Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery
The goal of this clinical trial is to learn whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.
The main questions this study aims to answer are:
Read more
Does intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.
Participants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.
Read the detailed description
This multicenter, prospective, randomized, double-blind, controlled clinical trial will evaluate whether preoperative intranasal dexmedetomidine or esketamine can reduce negative postoperative behavioral changes in children undergoing day surgery under general anesthesia. The study will also explore whether perioperative electroencephalographic (EEG) features are associated with these behavioral changes and may help explain the effects of the study drugs.
A total of 342 children undergoing elective day surgery will be enrolled across four centers. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive intranasal dexmedetomidine 2.0 micrograms/kg, intranasal esketamine 1.0 mg/kg, or an equal volume of normal saline approximately 30 minutes before induction of anesthesia. Study medications will be prepared in identical, unlabeled nasal spray devices to maintain blinding. Participants, investigators, and outcome assessors will remain unaware of treatment assignment throughout the study.
After study drug administration, participants will undergo routine perioperative monitoring. Sedation will be assessed before surgery. During anesthesia and recovery, EEG and other perioperative clinical data will be collected. Postoperative assessments will include pain and emergence delirium. Negative postoperative behavioral changes will be evaluated on postoperative days 3, 7, and 28. The primary outcome is the incidence of negative postoperative behavioral changes on postoperative day 7. Secondary analyses will assess behavioral outcomes at postoperative days 3 and 28 and examine the relationship between perioperative EEG patterns and postoperative behavioral changes.
This study is designed to provide evidence on the comparative effects of intranasal dexmedetomidine and esketamine on postoperative behavioral recovery in children undergoing day surgery and to identify perioperative EEG markers that may be associated with adverse behavioral outcomes.
- Conditions
- Behavior Problem
- Being tested
- Dexmedetomidine, Esketamine, Normal Saline
- Keywords
- Dexmedetomidine, Esketamine, Intranasal Premedication, Pediatric Day Surgery, Negative Postoperative Behavioral Changes, Emergence Delirium, Perioperative Electroencephalography, General Anesthesia, Children, Randomized Controlled Trial
- 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.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride
Intranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia.
EsketamineDrug
Also called Esketamine Hydrochloride
Intranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia.
Normal SalineDrug
Also called 0.9% Sodium Chloride
Intranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Dexmedetomidine | Experimental | Participants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia. Receives: Drug: Dexmedetomidine |
| Intranasal Esketamine | Experimental | Participants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia. Receives: Drug: Esketamine |
| Normal Saline Control | Placebo comparator | Participants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative Day 7
Secondary outcomes (2)
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative Day 3
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Postoperative Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital, Nanjing First Hospital, Nanjing Medical University, Wuxi Women's & Children's Hospital
- Responsible party
- Principal investigator, Sun Fei, Nanjing Children's Hospital
- Investigators
- fei sun, Master's, Principal investigator, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570160
- Sponsor's protocol ID
- 202512066-2
- Other IDs
- SWYY2025002065
- Acronym
- PEDI-NPOBCs
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there are no plans to share individual participant data (IPD) from this study. The decision may be revisited in the future based on data confidentiality, privacy concerns, and any relevant regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Association of Perioperative Electroencephalographic Changes Following Preoperative Intranasal Dexmedetomidine or Esketamine With Negative Postoperative Behavioral Changes in Children Undergoing Day Surgery
- ClinicalTrials.gov ID
- NCT07570160
- Acronym / sponsor ID
- PEDI-NPOBCs / 202512066-2
- Conditions
- Behavior Problem
- Keywords
- Dexmedetomidine, Esketamine, Intranasal Premedication, Pediatric Day Surgery, Negative Postoperative Behavioral Changes, Emergence Delirium, Perioperative Electroencephalography, General Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Collaborators
- Zhongda Hospital, Nanjing First Hospital, Nanjing Medical University, Wuxi Women's & Children's Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 May 2026 (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 whether intranasal dexmedetomidine or esketamine given before anesthesia can reduce negative postoperative behavioral changes in children undergoing day surgery. Negative postoperative behavioral changes may include anxiety, sleep problems, nightmares, irritability, or other unusual behaviors after surgery. This study will also examine whether changes in brain wave patterns during the perioperative period are related to these behavioral changes.
The main questions this study aims to answer are:
Does intranasal dexmedetomidine reduce negative postoperative behavioral changes in children after day surgery? Does intranasal esketamine reduce negative postoperative behavioral changes in children after day surgery? Are perioperative electroencephalographic (EEG) features associated with negative postoperative behavioral changes? Researchers will compare intranasal dexmedetomidine, intranasal esketamine, and normal saline to see whether these treatments differ in their effects on postoperative behavior and perioperative EEG features.
Participants will be randomly assigned to receive intranasal dexmedetomidine, intranasal esketamine, or intranasal normal saline about 30 minutes before anesthesia. They will receive routine perioperative monitoring, including EEG monitoring during surgery and recovery. They will also be assessed for sedation, pain, and emergence delirium. Follow-up assessments of postoperative behavioral changes will be completed on postoperative days 3, 7, and 28.
Detailed description
This multicenter, prospective, randomized, double-blind, controlled clinical trial will evaluate whether preoperative intranasal dexmedetomidine or esketamine can reduce negative postoperative behavioral changes in children undergoing day surgery under general anesthesia. The study will also explore whether perioperative electroencephalographic (EEG) features are associated with these behavioral changes and may help explain the effects of the study drugs.
A total of 342 children undergoing elective day surgery will be enrolled across four centers. Eligible participants will be randomly assigned in a 1:1:1 ratio to receive intranasal dexmedetomidine 2.0 micrograms/kg, intranasal esketamine 1.0 mg/kg, or an equal volume of normal saline approximately 30 minutes before induction of anesthesia. Study medications will be prepared in identical, unlabeled nasal spray devices to maintain blinding. Participants, investigators, and outcome assessors will remain unaware of treatment assignment throughout the study.
After study drug administration, participants will undergo routine perioperative monitoring. Sedation will be assessed before surgery. During anesthesia and recovery, EEG and other perioperative clinical data will be collected. Postoperative assessments will include pain and emergence delirium. Negative postoperative behavioral changes will be evaluated on postoperative days 3, 7, and 28. The primary outcome is the incidence of negative postoperative behavioral changes on postoperative day 7. Secondary analyses will assess behavioral outcomes at postoperative days 3 and 28 and examine the relationship between perioperative EEG patterns and postoperative behavioral changes.
This study is designed to provide evidence on the comparative effects of intranasal dexmedetomidine and esketamine on postoperative behavioral recovery in children undergoing day surgery and to identify perioperative EEG markers that may be associated with adverse behavioral outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine | Experimental | Drug: DexmedetomidineParticipants receive intranasal dexmedetomidine 2.0 micrograms/kg approximately 30 minutes before induction of general anesthesia. |
| Intranasal Esketamine | Experimental | Drug: EsketamineParticipants receive intranasal esketamine 1.0 mg/kg approximately 30 minutes before induction of general anesthesia. |
| Normal Saline Control | Placebo comparator | Drug: Normal SalineParticipants receive an equal volume of intranasal normal saline approximately 30 minutes before induction of general anesthesia. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 2 to 12 years.
- Scheduled to undergo elective day surgery under general anesthesia.
- ASA (American Society of Anesthesiologists) physical status I to III.
Key exclusion criteria (9 listed)
- Congenital diseases or severe liver or kidney dysfunction.
- History of allergic reactions to study drugs.
- Neuromuscular diseases, cerebral palsy, epilepsy.
- Other psychiatric or neurological disorders.
- Body mass index (BMI) ≥ 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 |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine HydrochlorideIntranasal dexmedetomidine 2.0 micrograms/kg administered once approximately 30 minutes before induction of general anesthesia. | Drug | Intranasal Dexmedetomidine |
| EsketamineAlso: Esketamine HydrochlorideIntranasal esketamine 1.0 mg/kg administered once approximately 30 minutes before induction of general anesthesia. | Drug | Intranasal Esketamine |
| Normal SalineAlso: 0.9% Sodium ChlorideIntranasal normal saline of equal volume administered once approximately 30 minutes before induction of general anesthesia. | Drug | Normal Saline Control |
Primary outcome
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7
Time frame: Postoperative Day 7
Incidence of negative postoperative behavioral changes assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
2 secondary outcomes
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 3
Time frame: Postoperative Day 3
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 28
Time frame: Postoperative Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. At this time, there are no plans to share individual participant data (IPD) from this study. The decision may be revisited in the future based on data confidentiality, privacy concerns, and any relevant regulatory requirements.
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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.
fei sun, Master's principal investigator
Children's Hospital of Nanjing Medical University
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 Dexmedetomidine, Esketamine and Normal Saline in people with Behavior Problem, run by Nanjing Children's 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 9 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: opening soon, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fei Sun, Master's degree (+86 181 0061 9994, drsunfei89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Negative Postoperative Behavioral Changes on Postoperative Day 7 (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 6 May 2026.