Intranasal dexmedetomidine versus oral midazolam for premedication in children having elective inguinal or urological surgery
Official title: Comparison of Intranasal Dexmedetomidine and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Inguinal and Urological Surgery: A Prospective, Randomized, Double-Blind, Controlled Trial
Run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · NCT07565116 · Data updated 2026-11-12
This trial will test whether intranasal dexmedetomidine or oral midazolam works better to calm children aged 2–10 before elective inguinal or urological surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 10 Years |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital Academic / other |
| Locations | 1 site (Diyarbakır, Outside of the US) |
| Status | Recruiting |
| Started | May 5, 2026 |
| Main results expected | August 1, 2026 |
| Study ends | September 26, 2026 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT07565116 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2–10 years with ASA physical status I–II scheduled for elective inguinal or urological surgery whose parents or guardians can provide written informed consent.
✕Probably not a fit
Children with significant systemic disease, cardiac arrhythmias or congenital heart disease, neurological or behavioral disorders, nasal pathology, emergency surgery, or those on interacting chronic medications are excluded and unlikely to benefit from the results.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a randomized, double-blind, controlled design, children aged 2–10 undergoing elective inguinal or urological surgery will be assigned to receive either intranasal dexmedetomidine or oral midazolam prior to anesthesia induction. A double-dummy approach is used so each group receives both an oral and an intranasal preparation to preserve blinding. The primary outcome is the proportion of patients achieving adequate sedation at induction, with perioperative safety parameters and emergence agitation also recorded. The trial will compare effectiveness, onset of sedation, and adverse effects between the two premedication methods.
Why it matters
Potential benefit: If successful, the study could identify a premedication that more reliably calms children with fewer respiratory effects and smoother anesthesia induction.
How similar studies have gone: Previous randomized studies and meta-analyses indicate intranasal dexmedetomidine often provides effective sedation and anxiolysis in children and compares favorably to oral midazolam, although onset time and dosing differ across reports.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients aged 2-10 years * ASA physical status I-II * Scheduled for elective inguinal or urological surgery under general anesthesia * Both male and female patients * Written informed consent obtained from parents or legal guardians Exclusion Criteria: * Known allergy or hypersensitivity to dexmedetomidine or midazolam * Presence of significant systemic disease or organ dysfunction * Cardiac arrhythmia or congenital heart disease * Neurological or behavioral disorders, including developmental delay * Chronic use of analgesics or other medications that may affect study outcomes * Anticipated difficult airway * Nasal pathology that may interfere with intranasal drug administration * Emergency surgery * Inability to obtain written informed consent from parents or legal guardians
Where it's running
-
Siyament Cangir
Diyarbakır, Outside of the US, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Siyament Cangir, M.D.
- Email: siyamentcangir@gmail.com
- Phone: +905534411047
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.