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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069638
• Other study ID #: INDEXJIA
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: December 18, 2023

Study information

• Verified date: December 2023
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 18, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Inflammation
• Joint Inflammation
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Dexmedetomidine
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
• Sedatives/Hypnotics,Other
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)

Locations

Country	Name	City	State
Finland	Oulu university hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Capnometry	Capnometry detects the exhaled carbon dioxide.	Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
Secondary	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.
Secondary	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.