## Protocol Section
### Identification Module
**NCT ID:** NCT06417125

**Brief Title:** 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

#### Organization Study ID Info
**ID:** K2024-01-006
#### Organization
**Class:** OTHER
**Full Name:** Fujian Provincial Hospital
### Status Module
#### Completion Date
**Date:** 2025-06-22

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-05-22

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-22

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Fujian Maternity and Child Health Hospital

**Class:** UNKNOWN

**Name:** Fujian Children's Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Fujian Provincial Hospital

#### Responsible Party

**Investigator Affiliation:** Fujian Provincial Hospital

**Investigator Full Name:** Yao Yusheng

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Behavior Problem

**Keywords:**

- dexmedetomidine

- midazolam

- postoperative negative behavior change

- emergence delirium

- tonsillectomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 324

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.

**Intervention Names:**

- Drug: Dexmedetomidine Hydrochloride

- Drug: Glucose solution

**Label:** Dexmedetomidine group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.

**Intervention Names:**

- Drug: Midazolam

- Drug: normal Saline

**Label:** Midazolam group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.

**Intervention Names:**

- Drug: normal Saline

- Drug: Glucose solution

**Label:** Placebo group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dexmedetomidine group

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

**Name:** Dexmedetomidine Hydrochloride

**Other Names:**

- Dexmedetomidine hydrochloride Injection

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Midazolam group

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

**Name:** Midazolam

**Other Names:**

- Midazolam oral solution

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Midazolam group

- Placebo group

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

**Name:** normal Saline

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Dexmedetomidine group

- Placebo group

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

**Name:** Glucose solution

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Incidence of postoperative negative behavior changes

**Time Frame:** Day 7 postoperatively

#### Secondary Outcomes

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

**Measure:** Incidence of postoperative negative behavior changes

**Time Frame:** Day 1 postoperatively

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

**Measure:** Incidence of postoperative negative behavior changes

**Time Frame:** Day 3 postoperatively

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

**Measure:** Incidence of postoperative negative behavior changes

**Time Frame:** Day 30 postoperatively

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

**Measure:** Incidence of emergence delirium

**Time Frame:** Within 30 min after extubation

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

**Measure:** Preoperative anxiety

**Time Frame:** Before the intervention in holding area

**Description:** 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).

**Measure:** Length of postanesthesia care unit stay

**Time Frame:** Up to 60 minutes postoperatively

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

**Measure:** Emergence time

**Time Frame:** About up to 30 minutes postoperatively

**Description:** 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).

**Measure:** Parental satisfaction

**Time Frame:** Postoperative day 1

**Description:** 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.

**Measure:** Parental separation anxiety

**Time Frame:** After intervention 30 minutes

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

**Measure:** Postoperative pain intensity

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

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

**Measure:** Incidence of adverse events

**Time Frame:** Up to 24 hours postoperatively

### Eligibility Module

**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.

**Maximum Age:** 5 Years

**Minimum Age:** 2 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fjslyys@126.com

**Name:** Yusheng Yao, MD&PhD

**Phone:** +86-13559939629

**Role:** CONTACT

**Contact 2:**

**Email:** chensisi49@163.com

**Name:** Sisi Chen, MD

**Phone:** +86-15080109541

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Fujian Provincial Hospital

**Name:** Xiaochun Zheng, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**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.

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** We would like to share our individual deidentified participant data beginning three months following the publication of the main results.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6894

- Name: Delirium

- Relevance: LOW

- As Found: Unknown

- ID: M772

- Name: Emergence Delirium

- Relevance: LOW

- As Found: Unknown

- ID: M85

- Name: Problem Behavior

- Relevance: HIGH

- As Found: Behavior Problem

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000066553

- Term: Problem Behavior

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000058647

- Term: Adrenergic alpha-2 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000018757

- Term: GABA Modulators

- ID: D000018682

- Term: GABA Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: PsychDr

- Name: Psychotropic Drugs

### Intervention Browse Module - Browse Leaves

- ID: M22662

- Name: Dexmedetomidine

- Relevance: HIGH

- As Found: Hospitalized Patients

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: HIGH

- As Found: Procedure

- ID: M11845

- Name: Midazolam

- Relevance: HIGH

- As Found: Induction

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20827

- Name: GABA Modulators

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008874

- Term: Midazolam

- ID: D000020927

- Term: Dexmedetomidine

- ID: D000019999

- Term: Pharmaceutical Solutions

### Misc Info Module

- Version Holder: 2024-05-31
