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

NCT ID: NCT03069638

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2023-12-18

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.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis Joint Inflammation

Keywords

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sedation pediatrics intranasal sedation dexmedetomidine dinitrous oxide intra-articular joint injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intranasal dexmedetomidine

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)

Sedatives/Hypnotics,Other

Intervention Type DRUG

Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)

Nitrous oxide inhalation

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)

Sedatives/Hypnotics,Other

Intervention Type DRUG

Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)

Interventions

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Dexmedetomidine

Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)

Intervention Type DRUG

Sedatives/Hypnotics,Other

Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)

Intervention Type DRUG

Other Intervention Names

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Dinitrous oxide

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Outi Peltoniemi

PhD, Senior physician in Oulu University Hospital at the Department of Pediatrics (PICU)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu university hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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INDEXJIA

Identifier Type: -

Identifier Source: org_study_id