Clinical trial NCT06417125: Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children
Official title: Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Behavior Problem
Keywords: dexmedetomidine
midazolam
postoperative negative behavior change
emergence delirium
tonsillectomy
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Maternity and Child Health Hospital
name: Fujian Children's Hospital
First posted: 2024-05-16
Enrollment: 324
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status I or II;
2. Aged 2-5 years;
3. Scheduled for elective tonsillectomy and (or) adenoidectomy.

Exclusion Criteria:

1. Parents refusing to allow their children to participate;
2. Intake of sedative or analgesic medication within 48 hours before surgery;
3. Developmental delay;
4. Psychosis;
5. Body mass index \> 30 kg/m2;
6. Allergy to study drugs;
7. 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.;
8. Any other conditions that precluded study inclusion.

Primary outcomes:
measure: Incidence of postoperative negative behavior changes
timeFrame: Day 7 postoperatively
Secondary outcomes:
measure: Incidence of postoperative negative behavior changes
timeFrame: Day 1 postoperatively
measure: Incidence of postoperative negative behavior changes
timeFrame: Day 3 postoperatively
measure: Incidence of postoperative negative behavior changes
timeFrame: Day 30 postoperatively
measure: Incidence of emergence delirium
timeFrame: Within 30 min after extubation
measure: Preoperative anxiety
timeFrame: Before the intervention in holding area
measure: Length of postanesthesia care unit stay
timeFrame: Up to 60 minutes postoperatively
measure: Emergence time
timeFrame: About up to 30 minutes postoperatively
measure: Parental satisfaction
timeFrame: Postoperative day 1
measure: Parental separation anxiety
timeFrame: After intervention 30 minutes
measure: Postoperative pain intensity
timeFrame: After extubation 10, 20, 30 min, and postoperative 1 day
measure: Incidence of adverse events
timeFrame: Up to 24 hours postoperatively
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Xiaochun Zheng, MD
role: STUDY_CHAIR
References: