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NCT Number: NCT06417125

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

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

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.

Other names: Dexmedetomidine hydrochloride Injection

midazolam

Drug

Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.

Other names: Midazolam oral solution

normal saline

Drug

Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

Glucose solution

Drug

Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Incidence of postoperative negative behavior changes

    Time frame: Day 1 postoperatively

    Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  2. Incidence of postoperative negative behavior changes

    Time frame: Day 3 postoperatively

    Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  3. Incidence of postoperative negative behavior changes

    Time frame: Day 30 postoperatively

    Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).

  4. Incidence of emergence delirium

    Time frame: Within 30 min after extubation

    Emergence delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale (defined as a PAED score of ≥10).

  5. Preoperative anxiety

    Time frame: Before the intervention in holding area

    Preoperative anxiety will be assessed using the modified Yale preoperative anxiety scale. Scores range from 23 to 100 with higher scores indicating greater anxiety.

  6. Length of postanesthesia care unit stay

    Time frame: Up to 60 minutes postoperatively

    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).

  7. Emergence time

    Time frame: About up to 30 minutes postoperatively

    Emergence time is defined as the interval from discontinuation of inhalation anesthetic to eye-opening on verbal command.

  8. Parental satisfaction

    Time frame: Postoperative day 1

    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).

  9. Parental separation anxiety

    Time frame: After intervention 30 minutes

    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.

  10. Postoperative pain intensity

    Time frame: After extubation 10, 20, 30 min, and postoperative 1 day

    Postoperative pain intensity will be measured using the face, legs, activity, cry, and consolability sacle.

  11. Incidence of adverse events

    Time frame: Up to 24 hours postoperatively

    Adverse events such as bradycardia, tachycardia, hypertension, hypotension, and hypoxia will be recorded during the trial.

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Collaborators

  • Fujian Maternity and Child Health Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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