drugset / Trial / NCT03564093

Intranasal Dexmedetomidine Sedation and Analgesia During Pediatric Emergency Room Procedures

NCT03564093 ↗

Phase 4 Unknown 112 enrolled University of Oulu
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study objective is to determine if intranasal dexmedetomidine is a safe and effective sedative drug during small painful procedures in the pediatric emergency room. Patients of the pediatric emergency room at Oulu university hospital with any medical condition requiring a small painful procedure like i.v. cannulation or lumbar puncture are asked to join the investigator's study if they would seem to benefit from a sedative drug during the procedure. Patients are randomly assigned to treatment group receiving intranasal dexmedetomidine 1µg/kg and to placebo group receiving 4,5% saline solution. The primary outcome is the success of the procedure. Cardiovascular and respiratory effects, the pain experienced by the patient, sedation scores and duration of crying are also monitored.

Timeline

Start
2018-03-15
Primary completion
2025-03-14
Completion
2025-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intranasal

Indications

No indication recorded.