Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children

Behavior Problem Clinical Trial

Official title:

Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06417125
• Other study ID #: K2024-01-006
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 22, 2024
• Est. completion date: June 22, 2025

Study information

• Verified date: May 2024
• Source: Fujian Provincial Hospital
• Contact: Yusheng Yao, MD&PhD
• Phone: +86-13559939629
• Email: fjslyys[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. completion date: June 22, 2025
• Est. primary completion date: May 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior Problem
• Problem Behavior

Intervention

Drug:
• Dexmedetomidine Hydrochloride
Patients were premedicated with intranasal dexmedetomidine 2 µg/kg in the holding area.
• Midazolam
Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.
• normal Saline
Patients were premedicated with normal saline 0.02 mL/kg in the holding area.
• Glucose solution
Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Fujian Provincial Hospital	Fujian Children's Hospital, Fujian Maternity and Child Health Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative negative behavior changes	Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).	Day 7 postoperatively
Secondary	Incidence of postoperative negative behavior changes	Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).	Day 1 postoperatively
Secondary	Incidence of postoperative negative behavior changes	Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).	Day 3 postoperatively
Secondary	Incidence of postoperative negative behavior changes	Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).	Day 30 postoperatively
Secondary	Incidence of emergence delirium	Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of =10).	Within 30 min after extubation
Secondary	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.	Before the intervention in holding area
Secondary	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).	Up to 60 minutes postoperatively
Secondary	Emergence time	Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command.	About up to 30 minutes postoperatively
Secondary	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).	Postoperative day 1
Secondary	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.	After intervention 30 minutes
Secondary	Postoperative pain intensity	Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability sacle.	After extubation 10, 20, 30 min, and postoperative 1 day
Secondary	Incidence of adverse events	Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.	Up to 24 hours postoperatively