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The use of intranasal dexmedetomidine for pediatric sedation in non-invasive radiological procedures (CTMS 004321) Assessing the efficacy and safety profile of intranasal dexmedetomidine for procedural sedation in radiological procedures in children with a prospective exploratory interventional monocentric study in a tertiary center in Antwerp (Belgium)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522778-34-00
Enrollment
100
Registered
2025-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation in healthy children

Brief summary

Success rate after one dose of intranasal dexmedetomidine

Detailed description

Success rate after an additional dose of intranasal dexmedetomidine (when adequate sedation is not reached after the first dose), Time to the onset of sedation after the first administration of intranasal dexmedetomidine (minutes), Duration of the sedation (minutes), Duration of the procedure (minutes), Waiting time until procedure (minutes), Total length of hospital stay (minutes), Prevalence of side effects

Interventions

DRUGDexmedetomidine 100 micrograms/ml concentrate for solution for infusion

Sponsors

Universitair Ziekenhuis Antwerpen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Success rate after one dose of intranasal dexmedetomidine—

Secondary

MeasureTime frame
Success rate after an additional dose of intranasal dexmedetomidine (when adequate sedation is not reached after the first dose), Time to the onset of sedation after the first administration of intranasal dexmedetomidine (minutes), Duration of the sedation (minutes), Duration of the procedure (minutes), Waiting time until procedure (minutes), Total length of hospital stay (minutes), Prevalence of side effects—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026