Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-31

Brief Summary

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The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:

Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?

How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?

Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.

Participants will:

Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.

Undergo sedation scoring at 15 and 30 minutes after drug administration.

Be assessed for ease of separation from parents and acceptance of anesthesia mask.

Be monitored for vital signs, recovery times, and any perioperative adverse events.

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Detailed Description

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Conditions

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Preoperative Anxiety Experienced by the Pediatric Patient Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to one of two treatment arms

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double Blind

Study Groups

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Dexmedetomidine + Midazolam 0.4 mg/kg

Group Type EXPERIMENTAL

Dexmedetomidine + Midazolam 0.4 mg/kg

Intervention Type DRUG

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.

Dexmedetomidine + Midazolam 0.2 mg/kg

Group Type EXPERIMENTAL

Dexmedetomidine + Midazolam 0.2 mg/kg

Intervention Type DRUG

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.

Interventions

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Dexmedetomidine + Midazolam 0.4 mg/kg

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.

Intervention Type DRUG

Dexmedetomidine + Midazolam 0.2 mg/kg

Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pediatric patients aged 1 to 8 years
* Scheduled for elective surgery under general anesthesia
* Surgery duration \< 1 hour
* ASA physical status I or II
* Parent or legal guardian able to provide informed consent

Exclusion Criteria

* Refusal to participate by parent/guardian
* Nasal infections, pathology, or epistaxis
* Runny nose or upper respiratory tract infection
* Enlarged adenoids
* BMI \> 30
* Known allergy to dexmedetomidine or midazolam
* Fever on day of surgery
* Coagulopathy
* Scheduled for cardiothoracic or neurosurgical procedures
* Congenital heart disease
* Neurological or mental disorders
* Pre-existing sedation (MOASS \< 5) on the day of surgery

Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No