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Clinical trial

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

ID
Name
INDEXJIA
Description
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.
Trial arms
Trial start
2017-02-01
Estimated PCD
2023-12-18
Trial end
2023-12-18
Status
Completed
Phase
Early phase I
Treatment
Dexmedetomidine
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
Arms:
Intranasal dexmedetomidine, Nitrous oxide inhalation
Sedatives/Hypnotics,Other
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
Arms:
Intranasal dexmedetomidine, Nitrous oxide inhalation
Other names:
Dinitrous oxide
Size
68
Primary endpoint
Visual Analog scale (VAS)
The VAS score is assessed after procedure when the patients have recovered from the sedation and are being discharged. The time of discharge is 1 to 5 hours after the injection procedure.
Eligibility criteria
Inclusion Criteria: * Patient age between ages 1year to 18 years * A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist Exclusion Criteria: * Patients under the age of 1year and over the age of 18years are excluded as well as patients needing injection therapy to more than 5 joints.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 68, 'type': 'ACTUAL'}}
Updated at
2023-12-20

1 organization

2 products

2 indications

Organization
University of Oulu
Product
Dexmedetomidine
Indication
Juvenile Idiopathic Arthritis
Indication
Arthritis
Product
Sedatives/Hypnotics,Other