Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

University of Indonesia (UI)

Status and phase: Completed; Phase 3

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

Treatments: Drug: 0.9% NaCl solution; Drug: Intranasal dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06991647

24-09-1444

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% NaCl solution

Intranasal dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Intranasal dexmedetomidine