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

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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

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE February 1, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • 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
  • 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 and pulse oxymetry.
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
Official Title  ICMJE Intranasal Dexmedetomidine Sedation During Intra-articular Joint Injections in Pediatric Population
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Juvenile Idiopathic Arthritis
  • Joint Inflammation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Sedatives/Hypnotics,Other
  • 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.
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Sedatives/Hypnotics,Other
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2017)
109
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Outi Peltoniemi, PhD +35883155837 outi.peltoniemi@ppshp.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03069638
Other Study ID Numbers  ICMJE INDEXJIA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Outi Peltoniemi, University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Oulu
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP