NCT03069638

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Juvenile Idiopathic Arthritis
• Joint Inflammation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
DRUG	Sedatives/Hypnotics,Other	Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)

Timeline

• Start date: 2017-02-01
• Primary completion: 2023-12-18
• Completion: 2023-12-18
• First posted: 2017-03-03
• Last updated: 2023-12-20

Locations

1 site across 1 country: Finland