Behavior ProblemPhase 4NCT06417125
Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children
A Phase 4 study testing Dexmedetomidine Hydrochloride, Midazolam 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 dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Behavior Problem
- What is being tested?
- Dexmedetomidine Hydrochloride, Midazolam and normal Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2024to 21 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I or II;
- Aged 2-5 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.
About this study
Official title: Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
The goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are:
- Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam?
- Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Read more
Participants will:
- Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication
- Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30
Read the detailed description
Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children.
Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children.
This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.
- Conditions
- Behavior Problem
- Being tested
- Dexmedetomidine Hydrochloride, Midazolam, normal Saline, Glucose solution
- Keywords
- dexmedetomidine, midazolam, postoperative negative behavior change, emergence delirium, tonsillectomy
- 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.
Dexmedetomidine HydrochlorideDrug
Also called Dexmedetomidine hydrochloride Injection
Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.
MidazolamDrug
Also called Midazolam oral solution
Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.
normal SalineDrug
Patients were premedicated with normal saline 0.02 mL/kg in the holding area.
Glucose solutionDrug
Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group | Experimental | Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg. Receives: Drug: Dexmedetomidine Hydrochloride; Drug: Glucose solution |
| Midazolam group | Active comparator | Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg. Receives: Drug: Midazolam; Drug: normal Saline |
| Placebo group | Placebo comparator | Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg. Receives: Drug: normal Saline; Drug: Glucose solution |
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 will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Day 7 postoperatively
Secondary outcomes (11)
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Day 1 postoperatively
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Day 3 postoperatively
Incidence of postoperative negative behavior changes
Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
Measured: Day 30 postoperatively
Incidence of emergence delirium
Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).
Measured: Within 30 min 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
Length of postanesthesia care unit stay
Length of postanesthesia care unit 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
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
Parental separation anxiety
Preoperative sedation level will be measured using the parental separation anxiety scale (PSAS). The PSAS is a 4-point scale as follows: 1=easy separation; 2=whimpers; 3=cries and cannot be easily reassured, but not clinging to parents; and 4=crying and clinging to parents. A PSAS score of 1 or 2 was considered as "acceptable" separation.
Measured: After intervention 30 minutes
Postoperative pain intensity
Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability sacle.
Measured: After extubation 10, 20, 30 min, and postoperative 1 day
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 posted16 May 2024
- Study start22 May 2024
- Primary completion22 Sep 2025
- Study completion21 Oct 2025
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Maternity and Child Health Hospital
- 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
- NCT06417125
- Sponsor's protocol ID
- K2024-01-006
- Status last verified
- Jul 2026
- First submitted
- 9 May 2024
- Last updated
- 30 Jul 2026
- 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06417125
- Acronym / sponsor ID
- K2024-01-006
- Conditions
- Behavior Problem
- Keywords
- dexmedetomidine, midazolam, postoperative negative behavior change, emergence delirium, tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Collaborators
- Fujian Maternity and Child Health Hospital
- Study start
- 22 May 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 16 May 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 dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are:
- Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam?
- Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
- Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication
- Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30
Detailed description
Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children.
Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children.
This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: Dexmedetomidine Hydrochloride, Drug: Glucose solutionParticipants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg. |
| Midazolam group | Active comparator | Drug: Midazolam, Drug: normal SalineParticipants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg. |
| Placebo group | Placebo comparator | Drug: normal Saline, Drug: Glucose solutionParticipants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I or II;
- Aged 2-5 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 |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: Dexmedetomidine hydrochloride InjectionPatients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area. | Drug | Dexmedetomidine group |
| MidazolamAlso: Midazolam oral solutionPatients were premedicated with oral midazolam 0.5 mg/kg in the holding area. | Drug | Midazolam group |
| normal SalinePatients were premedicated with normal saline 0.02 mL/kg in the holding area. | Drug | Midazolam group, Placebo group |
| Glucose solutionPatients were premedicated with oral sweet solution 0.25 mL/kg in the holding area. | Drug | Dexmedetomidine group, Placebo group |
Primary outcome
Incidence of postoperative negative behavior changes
Time frame: Day 7 postoperatively
Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
11 secondary outcomes
Incidence of postoperative negative behavior changes
Time frame: Day 1 postoperatively
Incidence of postoperative negative behavior changes
Time frame: Day 3 postoperatively
Incidence of postoperative negative behavior changes
Time frame: Day 30 postoperatively
Incidence of emergence delirium
Time frame: Within 30 min after extubation
Preoperative anxiety
Time frame: Before the intervention in holding area
Length of postanesthesia care unit stay
Time frame: Up to 60 minutes postoperatively
Emergence time
Time frame: About up to 30 minutes postoperatively
Parental satisfaction
Time frame: Postoperative day 1
Parental separation anxiety
Time frame: After intervention 30 minutes
Postoperative pain intensity
Time frame: After extubation 10, 20, 30 min, and postoperative 1 day
Incidence of adverse events
Time frame: Up to 24 hours postoperatively
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 30 Jul 2026.
- 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 Dexmedetomidine Hydrochloride, Midazolam 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: finished, as of the sponsor's last update on 30 Jul 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?
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?
Incidence of postoperative negative behavior changes (time frame: Day 7 postoperatively). 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 30 Jul 2026.