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NCT Number: NCT03069638

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Joint Inflammation Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oulu university hospital

Oulu, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Sedatives/Hypnotics,Other

Drug

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

Other names: Dinitrous oxide

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2017
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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