Joint Inflammation, Juvenile Idiopathic Arthritis
Conditions
Keywords
sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection
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.
Interventions
DRUGDexmedetomidine
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
DRUGSedatives/Hypnotics,Other
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
Sponsors
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | VAS scores of the pain experienced during the procedure are evaluated as a primary outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. | Heart rate is monitored by contiunously assessing Electro Cardiogram |
| Respiratory rate | Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. | Respiratory rate is detected by capnometer or assessed manually |
| FLACC | Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged. | The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children |
| Blood pressure | Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. | Blood pressure is measured indirectly with a cuff |
| Capnometry | Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration. | Capnometry detects the exhaled carbon dioxide. |
| Pulse oxymetry | Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration. | Oxygen saturation is measured by pulse oxymetry |
| Visual Analog scale (VAS) | At the follow up visit which usually is 2-12 weeks after the injection. | VAS scores of the pain experienced during the procedure evaluated at the follow up visit. |
| COMFORT-B | 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. | COMFORT-B is a sedation scale used to assess the level of sedation in children. |
Countries
Finland
Outcome results
None listed