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

Study Overview
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Brief Summary
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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.

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

Conditions
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Juvenile Idiopathic Arthritis, Joint Inflammation

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Sedatives/Hypnotics,Other


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal dexmedetomidine<br>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. | Drug: Dexmedetomidine<br>* Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)<br>Drug: Sedatives/Hypnotics,Other<br>* Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)<br>* Other names: Dinitrous oxide;|
| Active Comparator: Nitrous oxide inhalation<br>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. | Drug: Dexmedetomidine<br>* Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)<br>Drug: Sedatives/Hypnotics,Other<br>* Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)<br>* Other names: Dinitrous oxide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection