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Intranasal dexmedetomidine sedation and analgesia during minor procedures in the pediatric emergency room: Randomized double-blinded clinical trial

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518816-38-00
Acronym
OY072017
Enrollment
112
Registered
2024-11-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-05

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

Conditions

Patients of the pediatric emergency room at Oulu University Hospital with any medical condition requiring a minor painful procedure such as i.v. cannulation or lumbar puncture are asked to join our study if they would seem to benefit from a sedative drug during the procedure.

Brief summary

The success of the procedure at the first attempt

Detailed description

The duration of the procedure, Parents assessment of the patients comfortability during the procedure, Patient's and physician's assessment of the experienced pain with Visual Analog Scale, Assessment of pain levels of the patient with FLACC-scores, Assessment of sedation levels of the patient with Comfort-B-scores, Duration of crying, The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo, Blood pressure measured by manometer, Respiratory rate assessed by capnometry, Oxygen saturation is measured by pulse oxymetry, Heart rate measured by ECG

Interventions

DRUGDEXMEDETOMIDINE
DRUGSODIUM CHLORIDE

Sponsors

Oulu University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
The success of the procedure at the first attempt

Secondary

MeasureTime frame
The duration of the procedure, Parents assessment of the patients comfortability during the procedure, Patient's and physician's assessment of the experienced pain with Visual Analog Scale, Assessment of pain levels of the patient with FLACC-scores, Assessment of sedation levels of the patient with Comfort-B-scores, Duration of crying, The parents and the emergency room nurses are asked whether they think the patient recieved the experimental drug or placebo, Blood pressure measured by manometer, Respiratory rate assessed by capnometry, Oxygen saturation is measured by pulse oxymetry, Heart rate measured by ECG

Countries

Finland

Outcome results

None listed

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