drugset / Trial / NCT03069638

Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population

NCT03069638 ↗

Phase 4 Completed 68 enrolled University of Oulu
RandomizedCrossoverOpen-labelTreatment

Summary

The main objective of this study is to evaluate the effectivity of intranasal dexmedetomidine sedation during intra-articular injection therapy. Intranasal dexmedetomidine is compared with dinitrous oxide (N2O) which has already been proven safe and effective sedation method during painful procedures in pediatric patients. In earlier studies the median VAS during intra-articular corticosteroid injections with patients receiving nitrous oxide has been 3 (Uziel et al 2008). Study hypothesis is that with intranasal dexmedetomidine sedation the VAS pain levels will be 1 unit lower.

Timeline

Start
2017-02-01
Primary completion
2023-12-18
Completion
2023-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 2 ug/kg Intranasal
Subject Dexmedetomidine Other / unclassified 4 ug/kg Intranasal
Subject dinitrous oxide Unknown 50 % Inhaled