CompletedPhase 3

Effectiveness of Intranasal Dexmedetomidine Premedication in Child Intubation

Indonesia40 participantsStarted 2024-10-28

Plain-language 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.

Who can participate

Age range

1 Year – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean arterial pressure

Timeframe: immediately before premedication and immediately after intubation

Heart rate

Timeframe: immediately before premedication and immediately after intubation

Mask acceptance

Timeframe: Before induction

Intubation duration

Timeframe: during intubation

Sedation Score

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

Opioid use

Timeframe: Immediately after intubation

Trial details

NCT IDNCT06991647

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-28

View on ClinicalTrials.gov More Elective Surgical Procedure trials

Plain-language summary

Who can participate

Age range

1 Year – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean arterial pressure

Timeframe: immediately before premedication and immediately after intubation

Heart rate

Timeframe: immediately before premedication and immediately after intubation

Mask acceptance

Timeframe: Before induction

Intubation duration

Timeframe: during intubation

Sedation Score

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

Opioid use

Timeframe: Immediately after intubation