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

NCT03069638 | Completed Phase 4

• 1 other identifier: INDEXJIA
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Juvenile Idiopathic Arthritis; Joint Inflammation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Blood pressure

  Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.

• Heart rate

  Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.

• Heart rate

  Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.

• Respiratory rate

  Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.

• FLACC

  Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.

Study Arms (2)

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.

Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other

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.

Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other

Interventions

Dexmedetomidine DRUG

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

Intranasal dexmedetomidine; Nitrous oxide inhalation

Sedatives/Hypnotics,Other DRUG

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

Also known as: Dinitrous oxide

Intranasal dexmedetomidine; Nitrous oxide inhalation

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient age between ages 1year to 18 years
• A joint inflammation in 1-5 joints needing intra-articular corticosteroid injection diagnosed by pediatric rheumatologist

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu university hospital

Oulu, Finland

Location

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Interventions

Dexmedetomidine; Tranquilizing Agents

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Psychotropic Drugs

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior physician in Oulu University Hospital at the Department of Pediatrics (PICU)

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: March 3, 2017
• Study Start: February 1, 2017
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)