Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

Phase 3

Completed

• Conditions: Elective Surgical Procedure; ASA Physical Status I; ASA Physical Status II
• Interventions: Drug: 0.9% NaCl solution; Drug: Intranasal dexmedetomidine

• Registration Number: NCT06991647
• Lead Sponsor: Indonesia University

Brief Summary

The purpose of this study is to find out if a medicine called dexmedetomidine, given as a nasal spray, can help patients stay calm and comfortable before having a breathing tube placed (intubation). Researchers want to see if using this nasal spray affects blood pressure, heart rate, comfort with the oxygen mask, how quickly the tube is placed, and how sleepy patients become. They also want to check if patients who receive dexmedetomidine need less pain medicine (Fentanyl) during the procedure. Participants will receive either the dexmedetomidine nasal spray or a plain saltwater spray (placebo). Doctors will then measure blood pressure, heart rate, comfort levels, time needed for intubation, sleepiness, and the amount of pain medication used.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-28
• Primary Completion: 2024-12-28
• Study Completion: 2025-01-10
• Status Verified: 2025-05
• Study First Submitted: 2025-05-05
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children aged 1-6 years undergoing elective surgery
• ASA physical status 1 and 2

Exclusion Criteria

• Children with difficult airway
• Active infection in nasal and oral area
• Subjects with mental retardation, ADHD, and cerebral palsy
• Difficult intravenous access

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	0.9% NaCl solution	Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a nasal device.
Intranasal dexmedetomidine	Intranasal dexmedetomidine	Participants will receive intranasal dexmedetomidine at a dose of 2 mcg/kg body weight, diluted in 1 mL of 0.9% NaCl, administered using a 1 mL syringe connected to a nasal device.

Primary Outcome Measures

Name	Time	Method
Mask acceptance	Before induction	Measured using the Pediatric Anesthesia Behavior (PAB) scale. The PAB scale range from 1 to 3, with 1 indicating the best outcome (happy) and 3 the worst outcome (mad).
Intubation duration	during intubation	Measured using stopwatch, in seconds Started when inserting laryngoscope into the mouth, ended when end tidal CO2 is detected by the monitor
Sedation Score	Immediately upon arrival to the operating room, before induction of anesthesia	Sedation level was assessed using the COMFORT Behaviour Scale, which evaluates the child's sedation state after administration of dexmedetomidine. The total score ranges from 6 to 30, with the following interpretations: * Excessive sedation: 6-10; * Adequate sedation: 11-22; * Inadequate sedation: 23-30 Higher scores indicate less effective sedation control, whereas lower scores reflect deeper sedation.
Opioid use	Immediately after intubation	Amount of fentanyl (per kg body weight) used during intubation
Mean arterial pressure	immediately before premedication and immediately after intubation	Measured by non-invasive blood pressure monitoring
Heart rate	immediately before premedication and immediately after intubation	Measured by electrocardiography electrodes in vital sign monitor

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, Indonesia