Can a nasal spray make surgery less scary for kids?
NCT ID NCT06979791
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether adding dexmedetomidine to a lower dose of midazolam, both given as a nasal spray, can calm children aged 1 to 8 before elective surgery. The trial compares two doses of midazolam (0.4 mg/kg and 0.2 mg/kg) combined with the same dose of dexmedetomidine. Doctors measure how well children accept the anesthesia mask, how easily they separate from parents, and how quickly they recover, aiming to find a mix that works well with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A nasal spray combining dexmedetomidine and midazolam
- What this could lead to
- If it works, this could give anesthesiologists a gentler way to calm children before surgery, with fewer side effects than current options.
- What could go wrong
- This is a small, single-center Phase 2 trial. The combination may not calm children as well as hoped, or the lower midazolam dose may not be enough for some kids.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
60 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 year to 8 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pediatric patients aged 1 to 8 years * Scheduled for elective surgery under general anesthesia * Surgery duration \< 1 hour * ASA physical status I or II * Parent or legal guardian able to provide informed consent Exclusion Criteria: * Refusal to participate by parent/guardian * Nasal infections, pathology, or epistaxis * Runny nose or upper respiratory tract infection * Hepatic Dysfunction or significant liver disease * Epilepsy * BMI \> 30 * Known allergy to dexmedetomidine or midazolam * Fever on day of surgery * Coagulopathy * Scheduled for cardiothoracic or neurosurgical procedures * Congenital heart disease * Neurological or mental disorders * Pre-existing sedation (MOASS \< 5) on the day of surgery
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Kasr Al-Ainy Hospital, Cairo University
Cairo, 11956, Egypt
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