Clinical trial NCT03069638: Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Official title: Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Juvenile Idiopathic Arthritis
Joint Inflammation
Keywords: sedation
pediatrics
intranasal sedation
dexmedetomidine
dinitrous oxide
intra-articular joint injection
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 68
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Visual Analog scale (VAS)
timeFrame: 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 outcomes:
measure: Blood pressure
timeFrame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
measure: Heart rate
timeFrame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
measure: Heart rate
timeFrame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
measure: Respiratory rate
timeFrame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
measure: FLACC
timeFrame: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.
measure: COMFORT-B
timeFrame: 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.
measure: Capnometry
timeFrame: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
measure: Pulse oxymetry
timeFrame: Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.
measure: Visual Analog scale (VAS)
timeFrame: At the follow up visit which usually is 2-12 weeks after the injection.
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu university hospital
Study officials:
References: