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

Primary Purpose

Juvenile Idiopathic Arthritis, Joint Inflammation

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dexmedetomidine
Sedatives/Hypnotics,Other
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Oulu university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intranasal dexmedetomidine

Nitrous oxide inhalation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.

Secondary Outcome Measures

Blood pressure
Blood pressure is measured indirectly with a cuff
Heart rate
Heart rate is monitored by contiunously assessing Electro Cardiogram
Heart rate
Heart rate is monitored by contiunously assessing pulse oxymetry.
Respiratory rate
Respiratory rate is detected by capnometer or assessed manually
FLACC
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children
COMFORT-B
COMFORT-B is a sedation scale used to assess the level of sedation in children.
Capnometry
Capnometry detects the exhaled carbon dioxide.
Pulse oxymetry
Oxygen saturation is measured by pulse oxymetry
Visual Analog scale (VAS)
VAS scores of the pain experienced during the procedure evaluated at the follow up visit.

Full Information

First Posted
December 20, 2016
Last Updated
May 30, 2022
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT03069638
Brief Title
Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Official Title
Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis, Joint Inflammation
Keywords
sedation, pediatrics, intranasal sedation, dexmedetomidine, dinitrous oxide, intra-articular joint injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intranasal dexmedetomidine
Arm Type
Experimental
Arm 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.
Arm Title
Nitrous oxide inhalation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
Intervention Type
Drug
Intervention Name(s)
Sedatives/Hypnotics,Other
Other Intervention Name(s)
Dinitrous oxide
Intervention Description
Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
Primary Outcome Measure Information:
Title
Visual Analog scale (VAS)
Description
VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.
Time Frame
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 Measure Information:
Title
Blood pressure
Description
Blood pressure is measured indirectly with a cuff
Time Frame
Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Title
Heart rate
Description
Heart rate is monitored by contiunously assessing Electro Cardiogram
Time Frame
Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Title
Heart rate
Description
Heart rate is monitored by contiunously assessing pulse oxymetry.
Time Frame
Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Title
Respiratory rate
Description
Respiratory rate is detected by capnometer or assessed manually
Time Frame
Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration.
Title
FLACC
Description
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children
Time Frame
Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged.
Title
COMFORT-B
Description
COMFORT-B is a sedation scale used to assess the level of sedation in children.
Time Frame
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.
Title
Capnometry
Description
Capnometry detects the exhaled carbon dioxide.
Time Frame
Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration.
Title
Pulse oxymetry
Description
Oxygen saturation is measured by pulse oxymetry
Time Frame
Oxygen saturation by pulse oxymetry is measured continuously 20 minutes before the drug administration and for six hours after the drug administration.
Title
Visual Analog scale (VAS)
Description
VAS scores of the pain experienced during the procedure evaluated at the follow up visit.
Time Frame
At the follow up visit which usually is 2-12 weeks after the injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Outi Peltoniemi, PhD
Phone
+35883155837
Email
outi.peltoniemi@ppshp.fi
Facility Information:
Facility Name
Oulu university hospital
City
Oulu
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Outi Peltoniemi, MD, PhD
Phone
+35883155837
Email
outi.peltoniemi@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Miikka Tervonen, MD
Phone
+35883158428
Email
miikka.tervonen@oulu.fi

12. IPD Sharing Statement

Plan to Share IPD
No

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

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