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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Behavior Problem
• Intervention / Treatment: Drug: Dexmedetomidine Hydrochloride; Drug: Glucose solution; Drug: Midazolam; Drug: normal Saline

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 Type: Interventional
• Enrollment (Estimated): 324
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yusheng Yao, MD&PhD; Phone Number: +86-13559939629; Email: fjslyys@126.com
• Study Contact Backup: Name: Sisi Chen, MD; Phone Number: +86-15080109541; Email: chensisi49@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.	Drug: Dexmedetomidine Hydrochloride; Patients were premedicated with intranasal dexmedetomidine 2 μg/kg in the holding area.; Other Names: Dexmedetomidine hydrochloride Injection; Drug: Glucose solution; Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.
Active Comparator: Midazolam group; Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.	Drug: Midazolam; Patients were premedicated with oral midazolam 0.5 mg/kg in the holding area.; Other Names: Midazolam oral solution; Drug: normal Saline; Patients were premedicated with normal saline 0.02 mL/kg in the holding area.
Placebo Comparator: Placebo group; Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.	Drug: Glucose solution; Patients were premedicated with oral sweet solution 0.25 mL/kg in the holding area.; Drug: normal Saline; Patients were premedicated with normal saline 0.02 mL/kg in the holding area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fujian Provincial Hospital
• Collaborators: Fujian Maternity and Child Health Hospital; Fujian Children's Hospital
• Investigators: Study Chair: Xiaochun Zheng, MD, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 22, 2024
• Primary Completion (Estimated): May 22, 2025
• Study Completion (Estimated): June 22, 2025

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: midazolam; dexmedetomidine; tonsillectomy; emergence delirium; postoperative negative behavior change
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Dexmedetomidine; Pharmaceutical Solutions
• Other Study ID Numbers: K2024-01-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• IPD Sharing Access Criteria: All the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No