Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

NCT06991647 | Completed Phase 3

• 1 other identifier: 24-09-1444
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Surgical Procedure; ASA Physical Status I; ASA Physical Status II

Keywords

intranasal dexmedetomidine

Outcome Measures

Primary Outcomes (6)

• Mean arterial pressure

  Measured by non-invasive blood pressure monitoring

  immediately before premedication and immediately after intubation

• Heart rate

  Measured by electrocardiography electrodes in vital sign monitor

  immediately before premedication and immediately after intubation

• Mask acceptance

  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).

  Before induction

• Intubation duration

  Measured using stopwatch, in seconds Started when inserting laryngoscope into the mouth, ended when end tidal CO2 is detected by the monitor

  during intubation

• Sedation Score

  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.

  Immediately upon arrival to the operating room, before induction of anesthesia

• Opioid use

  Amount of fentanyl (per kg body weight) used during intubation

  Immediately after intubation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a nasal device.

Drug: 0.9% NaCl solution

Intranasal dexmedetomidine

EXPERIMENTAL

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.

Drug: Intranasal dexmedetomidine

Interventions

Intranasal dexmedetomidine DRUG

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 Teleflex MAD Nasal device while in the supine position. The soft tip of the device will be gently placed into each nostril without applying pressure. The solution will be sprayed slowly to create a fine mist. The total dose will be divided equally, with 0.5 mL delivered into each nostril, administered approximately 30 minutes before intubation during induction.

Intranasal dexmedetomidine

0.9% NaCl solution DRUG

Participants will receive 1 ml of 0.9% NaCl solution administered intranasally using a 1 ml syringe connected to a Teleflex MAD nasal device while in the supine position. The soft tip of the Teleflex MAD nasal device is gently placed into each nostril without applying pressure. The solution is slowly sprayed to create a fine mist for patient comfort. The dose is divided equally, delivering 0.5 ml into each nostril, approximately 30 minutes before intubation during induction.

Placebo

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Coordinator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 28, 2025
• Study Start: October 28, 2024
• Primary Completion: December 28, 2024
• Study Completion: January 10, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)