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    Clinical Trial Results:
    A prospective randomized open label study Intranasal dexmedetomidine versus inhaled nitrous oxide for children age 3 – 15 years for procedural sedation and analgesia in pediatric emergency department.

    Summary
    EudraCT number
    2016-003773-17
    Trial protocol
    SE  
    Global end of trial date
    28 Aug 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Feb 2024
    First version publication date
    19 Feb 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    dex_version1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Karolinska University Hospital
    Sponsor organisation address
    AnnaStecksens gatan, Stockholm, Sweden,
    Public contact
    Astrid Lindgrens Childrens hospital, Karolinska University Hospital, 46 851770000,
    Scientific contact
    Astrid Lindgrens Childrens hospital, Karolinska University Hospital, 46 851770000,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Aim of this study is to measure whether intranasal dexmedetomidine is equally good as nitrous oxide (N2O) among children between 3 and 15 years of age with minor injuries with respect to analgesia during procedure measured by FLACC in a prospective randomized open-label study. We are interested in finding out if dexmedetomidine could be used for PSA for painful procedures in combination with local anesthetics.
    Protection of trial subjects
    This trial was approved by the Swedish Ethical Review Authority, Stockholm. As all subject enrolled in this trial were minors and therefore vulnerable the risks and benefits of the treatments were carefully assessed. Informed consent was required from all caregivers. All data has been treated anonymously.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 156
    Worldwide total number of subjects
    156
    EEA total number of subjects
    156
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    117
    Adolescents (12-17 years)
    39
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patient recruitment was carried out in the pediatric ED at Astrid Lindgren Children’s hospital (ALB), Karolinska University Hospital in Stockholm, Sweden between August 2017 and October 2020

    Pre-assignment
    Screening details
    Swedish speaking, previously healthy children aged 3 to 15 years with an extremity fracture or luxation requiring reduction were eligible for this study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IN DEX
    Arm description
    Intranasal dexmedetomidine for procedural sedation and analgesia
    Arm type
    Experimental

    Investigational medicinal product name
    dexmedetomidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intranasal use
    Dosage and administration details
    2.0 mcg/kg intranasal with mucosal athomization devize (MAD)

    Arm title
    Nitrous oxide
    Arm description
    Inhaled Nitrous oxide for procedural sedation and analgesia
    Arm type
    Active comparator

    Investigational medicinal product name
    nitrous oxide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Medicinal gas, compressed
    Routes of administration
    Inhalation use
    Dosage and administration details
    N2O was administered with a facial mask held by an experienced ED nurse. N2O was titrated to a concentration 50% N2O : 50% O2 within 2-3 minutes. When N2O was discontinued supplemental 100% O2 was provided for 2-3 minutes.

    Number of subjects in period 1
    IN DEX Nitrous oxide
    Started
    78
    78
    Completed
    77
    78
    Not completed
    1
    0
         Physician decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IN DEX
    Reporting group description
    Intranasal dexmedetomidine for procedural sedation and analgesia

    Reporting group title
    Nitrous oxide
    Reporting group description
    Inhaled Nitrous oxide for procedural sedation and analgesia

    Reporting group values
    IN DEX Nitrous oxide Total
    Number of subjects
    78 78 156
    Age categorical
    Units: Subjects
        Children (2-11 years)
    59 58 117
        Adolescents (12-17 years)
    19 20 39
    Gender categorical
    Units: Subjects
        Female
    30 35 65
        Male
    48 43 91

    End points

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    End points reporting groups
    Reporting group title
    IN DEX
    Reporting group description
    Intranasal dexmedetomidine for procedural sedation and analgesia

    Reporting group title
    Nitrous oxide
    Reporting group description
    Inhaled Nitrous oxide for procedural sedation and analgesia

    Primary: pain

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    End point title
    pain
    End point description
    End point type
    Primary
    End point timeframe
    After procedure
    End point values
    IN DEX Nitrous oxide
    Number of subjects analysed
    77
    78
    Units: 10
    77
    78
    Statistical analysis title
    dex vs N2O
    Comparison groups
    Nitrous oxide v IN DEX
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    < 0.05
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: sedation

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    End point title
    sedation
    End point description
    End point type
    Secondary
    End point timeframe
    After procedure
    End point values
    IN DEX Nitrous oxide
    Number of subjects analysed
    77
    78
    Units: 6
    77
    78
    No statistical analyses for this end point

    Secondary: parental and patient satisfaction

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    End point title
    parental and patient satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    After procedure
    End point values
    IN DEX Nitrous oxide
    Number of subjects analysed
    77
    78
    Units: 5
    77
    78
    No statistical analyses for this end point

    Secondary: phycisians opinion

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    End point title
    phycisians opinion
    End point description
    End point type
    Secondary
    End point timeframe
    After procedure
    End point values
    IN DEX Nitrous oxide
    Number of subjects analysed
    77
    78
    Units: 5
    77
    78
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    August 2018 - August 2020
    Adverse event reporting additional description
    Reported to Swedish Medical authority
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    2.1
    Reporting groups
    Reporting group title
    dexmedetomidine
    Reporting group description
    -

    Reporting group title
    Nitrous oxide
    Reporting group description
    -

    Serious adverse events
    dexmedetomidine Nitrous oxide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    0 / 78 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.7%
    Non-serious adverse events
    dexmedetomidine Nitrous oxide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 77 (6.49%)
    9 / 78 (11.54%)
    Ear and labyrinth disorders
    tinnitus
    Additional description: Short, passed quicky with discontinuation of nitrous oxide
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    nausea and vomiting
    Additional description: Symptoms passed quickly with cessation of nitrous oxide
         subjects affected / exposed
    0 / 77 (0.00%)
    7 / 78 (8.97%)
         occurrences all number
    0
    0
    Psychiatric disorders
    Hallucinations, mixed
    Additional description: Shortterm and no medications were required to treat these symptoms
         subjects affected / exposed
    5 / 77 (6.49%)
    1 / 78 (1.28%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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