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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03069638
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Outi Peltoniemi, University of Oulu

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Joint Inflammation Drug: Dexmedetomidine Drug: Sedatives/Hypnotics,Other Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Dinitrous oxide




Primary Outcome Measures :
  1. Visual Analog scale (VAS) [ 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. ]
    VAS scores of the pain experienced during the procedure are evaluated as a primary outcome.


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. ]
    Blood pressure is measured indirectly with a cuff

  2. Heart rate [ Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. ]
    Heart rate is monitored by contiunously assessing Electro Cardiogram

  3. Heart rate [ Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. ]
    Heart rate is monitored by contiunously assessing pulse oxymetry.

  4. Respiratory rate [ Time Frame: Assessed in every 5 minutes 20 minutes before the drug administration and for six hours after the drug administration. ]
    Respiratory rate is detected by capnometer or assessed manually

  5. FLACC [ Time Frame: Before the injection procedure, during the injection procedure, 5 and 10 minutes after the procedure and when the patient is being discharged. ]
    The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children

  6. COMFORT-B [ 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. ]
    COMFORT-B is a sedation scale used to assess the level of sedation in children.

  7. Capnometry [ Time Frame: Assessed continuously 20 minutes before the drug administration and for six hours after the drug administration. ]
    Capnometry detects the exhaled carbon dioxide.

  8. 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. ]
    Oxygen saturation is measured by pulse oxymetry

  9. Visual Analog scale (VAS) [ Time Frame: At the follow up visit which usually is 2-12 weeks after the injection. ]
    VAS scores of the pain experienced during the procedure evaluated at the follow up visit.



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069638


Contacts
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Contact: Outi Peltoniemi, PhD +35883155837 outi.peltoniemi@ppshp.fi

Locations
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Finland
Oulu university hospital Recruiting
Oulu, Finland
Contact: Outi Peltoniemi, MD, PhD    +35883155837    outi.peltoniemi@ppshp.fi   
Contact: Miikka Tervonen, MD    +35883158428    miikka.tervonen@oulu.fi   
Sponsors and Collaborators
University of Oulu

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Responsible Party: Outi Peltoniemi, PhD, Senior physician in Oulu University Hospital at the Department of Pediatrics (PICU), University of Oulu
ClinicalTrials.gov Identifier: NCT03069638    
Other Study ID Numbers: INDEXJIA
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Outi Peltoniemi, University of Oulu:
sedation
pediatrics
intranasal sedation
dexmedetomidine
dinitrous oxide
intra-articular joint injection
Additional relevant MeSH terms:
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Arthritis, Juvenile
Inflammation
Arthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Dexmedetomidine
Nitrous Oxide
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Anesthetics, General
Anesthetics