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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
Oulu university hospital
Oulu, Finland
Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.
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.
Blood pressure
Blood pressure is measured indirectly with a cuff
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Heart rate is monitored by contiunously assessing Electro Cardiogram
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Heart rate
Heart rate is monitored by contiunously assessing pulse oxymetry.
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Respiratory rate
Respiratory rate is detected by capnometer or assessed manually
Time frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
FLACC
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children
Time frame: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.
COMFORT-B
COMFORT-B is a sedation scale used to assess the level of sedation in children.
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.
Capnometry
Capnometry detects the exhaled carbon dioxide.
Time frame: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
Pulse oxymetry
Oxygen saturation is measured by 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.
Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure evaluated at the follow up visit.
Time frame: At the follow up visit which usually is 2-12 weeks after the injection.
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