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

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Joint Inflammation; Juvenile Idiopathic Arthritis

Treatments: Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other

Study type: Interventional

Funder types: Other

Identifiers

NCT03069638

INDEXJIA

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

68 participants in 2 patient groups

Intranasal dexmedetomidine

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Sedatives/Hypnotics,Other

Nitrous oxide inhalation

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Drug: Sedatives/Hypnotics,Other