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

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis; Joint Inflammation
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Sedatives/Hypnotics,Other

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Outi Peltoniemi, PhD; Phone Number: +35883155837; Email: outi.peltoniemi@ppshp.fi

Study Locations

• Finland
  • Oulu, Finland
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; dexmedetomidine; sedation; intranasal sedation; dinitrous oxide; intra-articular joint injection
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Inflammation; Arthritis, Juvenile; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dexmedetomidine; Hypnotics and Sedatives
• Other Study ID Numbers: INDEXJIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No