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

NCT03069638 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-12-20

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069638 on ClinicalTrials.gov