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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal dexmedetomidine | Experimental | Dexmedetomidine is given once 4 micrograms per kilogram intranasally. If the sedation is not successful another 2 microgram per kilogram intranasal dose is given. Intravenous dexmedetomidine solution is administrated intranasally with MAD nasal drug delivery device and a syringe. |
|
| Nitrous oxide inhalation | Active Comparator | Dinitrousoxide (N2O) is given with Livopan administrating device. Livopan consists of 50% oxygen and 50% nitrous oxide. Gas mixture is inhaled 5 minutes before the injection procedure and during the injection procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog scale (VAS) | VAS scores of the pain experienced during the procedure are evaluated as a primary outcome. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Blood pressure is measured indirectly with a cuff | Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oulu university hospital | Oulu | Finland |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D014149 | Tranquilizing Agents |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sedatives/Hypnotics,Other | Drug | Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection) |
|
|
Heart rate is monitored by contiunously assessing Electro Cardiogram
| 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. | 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 | 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 | 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. | 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. | 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 | 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. | At the follow up visit which usually is 2-12 weeks after the injection. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002492 |
| Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D011619 | Psychotropic Drugs |