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NCT Number: NCT06991647

Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

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.

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Key information

Conditions

Elective Surgical Procedure ASA Physical Status I ASA Physical Status II

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cipto Mangunkusumo Hospital

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Mean arterial pressure

    Time frame: immediately before premedication and immediately after intubation

    Measured by non-invasive blood pressure monitoring

  2. Heart rate

    Time frame: immediately before premedication and immediately after intubation

    Measured by electrocardiography electrodes in vital sign monitor

  3. Mask acceptance

    Time frame: 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).

  4. Intubation duration

    Time frame: during intubation

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

  5. Sedation Score

    Time frame: 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.

  6. Opioid use

    Time frame: Immediately after intubation

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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Effectiveness of Adjuvant Premedication of Intranasal Dexmedetomidine on the Intubation Procedure in Children

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 28, 2025
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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