Home›Pediatrics› Dexmedetomidine nasal spray vs chloral hydrate for pediatric sedation: protocol only, no results yet
Dexmedetomidine nasal spray vs chloral hydrate for pediatric sedation: protocol only, no results yetNew plan to test nasal spray for calming children during exams
Frontiers in MedicinePublished September 25, 2026DOI ↗Editorial oversight: Dr. Sofia Müller, MD · Lifespan & Whole-Person Care
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Key Takeaway
Recognize this as a protocol only; no efficacy or safety conclusions can be drawn yet.
This publication is a protocol for a randomized controlled trial, not a report of completed results. The trial is planned as a single-center, outpatient study in children aged 2 to 6 years with ASA physical status I/II who require sedation for outpatient examinations. The planned sample size is 248 participants.
The planned intervention is dexmedetomidine hydrochloride nasal spray at 2 mcg/kg, compared with oral chloral hydrate syrup at 50 mg/kg. The primary outcome is sedation success rates. Secondary outcomes include sedation onset, sedation duration, MOAA/S sedation depth scores, Steward recovery status scores, and safety.
No main results are reported. Adverse events, serious adverse events, discontinuations, and tolerability are all not reported. Follow-up duration is not reported. Limitations, funding or conflicts of interest, practice relevance, and causality notes are also not reported.
Because this is a protocol, it provides no evidence on the comparative efficacy or safety of intranasal dexmedetomidine versus oral chloral hydrate in this population. Clinicians should not change practice based on this publication. The trial design addresses a relevant question in pediatric procedural sedation, but its findings will only become interpretable once the trial is completed and results are published.
How this fits prior evidence
This protocol addresses a question adjacent to prior coverage of intranasal dexmedetomidine plus midazolam, which was reported to improve sedation success versus chloral hydrate in children, with faster onset and events noted for chloral hydrate. The current protocol tests intranasal dexmedetomidine as monotherapy against oral chloral hydrate, rather than the combination regimen previously covered. Because no results are reported, this publication neither confirms nor contrasts the earlier finding; it sets up a future comparison. The prior coverage remains the only available evidence signal on this comparison in this publication.
Taking a child to a medical exam can be a stressful experience for both the child and the parents. To help keep kids calm and still during these checkups, doctors often use sedation. This new study plan looks at a different way to provide that calm.
Researchers plan to compare a nasal spray of dexmedetomidine with a traditional oral syrup called chloral hydrate. The study will involve 248 children between the ages of 2 and 6. The goal is to see which method works better for getting the children settled quickly and keeping them calm for the right amount of time.
Because this is a protocol, it means the study is still in the planning stages. No results have been collected yet, so we do not know if the nasal spray is safer or more effective than the current syrup. It is a step toward finding better ways to manage children's comfort during medical procedures.
What this means for you:
A new trial is being planned to see if nasal spray can replace oral syrup for calming children during exams.
Common questions
What is being tested for children's sedation?
The study plans to compare a dexmedetomidine hydrochloride nasal spray against an oral chloral hydrate syrup. The goal is to see which method is better for sedation success, how fast it works, and how long it lasts for children aged 2 to 6.
Is the nasal spray safe for young children?
Because this is a study protocol, no results have been reported yet. We do not have data on safety, side effects, or how well the patients tolerated the medication. You should talk to your doctor about the safest options for your child.
BackgroundChildren aged 2 to 6 years are prone to fear and resistance during medical examinations, necessitating sedation assistance. Traditional sedation modalities have limitations such as inconvenient operation, slow onset, or respiratory depression. Dexmedetomidine hydrochloride, a highly selective α₂-adrenergic receptor agonist, exerts sedative, analgesic, and anxiolytic effects with minimal respiratory and circulatory impacts. Its nasal spray is rapidly absorbed via the mucosa, avoiding the first-pass effect, and is thus suitable for young children. This study compares intranasal dexmedetomidine hydrochloride with oral chloral hydrate to evaluate the former's clinical efficacy and safety for pre-examination sedation in young children.MethodsThis is a single-center, prospective, randomized controlled trial conducted at the Children's Medical Center of the Affiliated Hospital of Southwest Medical University. A total of 248 children aged 2–6 years with ASA physical status I/II requiring sedation for outpatient examinations will be enrolled and randomized 1:1 to receive dexmedetomidine hydrochloride nasal spray (2μg/kg, experimental group) or oral chloral hydrate syrup (50 mg/kg, control group) via computer-generated random sequences. Vital signs will be monitored continuously; sedation onset/duration, MOAA/S (sedation depth), and Steward (recovery status) scores will be recorded. Adverse events will be observed to compare sedation success rates and safety between groups.Ethics and disseminationThis study has been approved by the Medical Ethics Committee of the Affiliated Hospital of Southwest Medical University (Approval No. KY2025368). Results will be disseminated via peer-reviewed publications and conference presentations.Clinical Trial Registrationhttps://www.chictr.org.cn/showproj.html?proj= 320640, ChiCTR2600126783.
