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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2024
• Main ID: NCT03069638
• Date of registration: 20/12/2016
• Prospective Registration: Yes
• Primary sponsor: University of Oulu
• Public title: Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
• Scientific title: Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
• Date of first enrolment: February 1, 2017
• Target sample size: 68
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03069638
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Finland

Key inclusion & exclusion 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.



Age minimum: 1 Year
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Joint Inflammation

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Sedatives/Hypnotics,Other

Drug: Dexmedetomidine

Primary Outcome(s)

Visual Analog scale (VAS) [Time Frame: 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.]

Secondary Outcome(s)

Capnometry [Time Frame: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.]

FLACC [Time Frame: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.]

Blood pressure [Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.]

COMFORT-B [Time Frame: Assessed 20 minutes before the drug administration and in every 15 minutes for six hours after the drug administration and during the injection procedure and 5 and 10 minutes after the injection.]

Heart rate [Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.]

Pulse oxymetry [Time Frame: Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.]

Respiratory rate [Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.]

Visual Analog scale (VAS) [Time Frame: At the follow up visit which usually is 2-12 weeks after the injection.]

Secondary ID(s)

INDEXJIA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors