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    Clinical Trial Results:
    Intraoperative clonidine for prevention of postoperative agitation in children anaesthetised with sevoflurane (PREVENT AGITATION): a randomised, placebo-controlled, double-blind trial

    Summary
    EudraCT number
    2014-001466-10
    Trial protocol
    DK  
    Global end of trial date
    08 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    24 Nov 2018
    First version publication date
    24 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MY-clonidin-1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02361476
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    National Committee on Biomedical Research Ethics: H-2-2014-072, Danish Data Protection Agency: 30-1348
    Sponsors
    Sponsor organisation name
    Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology
    Sponsor organisation address
    Blegdamsvej 9, Copenhagen, Denmark, 2100
    Public contact
    Mogens Ydemann, Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology, mogens@ydemann.dk
    Scientific contact
    Mogens Ydemann, Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology, mogens@ydemann.dk
    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
    08 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We aimed to assess the effects of intravenous clonidine administered intraoperatively on the incidence of postoperative agitation, pain, and adverse events.
    Protection of trial subjects
    All patients received the same protocol-based care.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Jan 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 379
    Worldwide total number of subjects
    379
    EEA total number of subjects
    379
    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)
    89
    Children (2-11 years)
    290
    Adolescents (12-17 years)
    0
    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
    We recruited children between January and December, 2015, from: Rigshospitalet, Copenhagen University Hospital, Copenhagen; Vejle Hospital, Vejle, and Zealand University Hospital, Køge

    Pre-assignment
    Screening details
    Children aged 1–5 years, with an American Society of Anesthesiologists physical classification score of 1–2, who were scheduled for anaesthesia with sevoflurane and fentanyl.

    Period 1
    Period 1 title
    inclusion (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Vials were identical, we masked the trial to all participants, investigators, other health-care providers, and statisticians. Additionally, we extended the masking to the authors of the abstract for this Article who initially drafted two versions

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    intervention
    Arm description
    3 μg/kg of intravenous clonidine - around 20 min before the end of surgery.
    Arm type
    Experimental

    Investigational medicinal product name
    clonidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    3 μg/kg of intravenous clonidine

    Arm title
    placebo
    Arm description
    equal quantity of intravenous isotonic saline - around 20 min before completion of surgery
    Arm type
    Placebo

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    equal quantity of intravenous isotonic saline

    Number of subjects in period 1
    intervention placebo
    Started
    191
    188
    Completed
    191
    188

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    intervention
    Reporting group description
    3 μg/kg of intravenous clonidine - around 20 min before the end of surgery.

    Reporting group title
    placebo
    Reporting group description
    equal quantity of intravenous isotonic saline - around 20 min before completion of surgery

    Reporting group values
    intervention placebo Total
    Number of subjects
    191 188 379
    Age categorical
    <2 years
    Units: Subjects
        <2 years
    46 43 89
        ≥2 years
    145 145 290
    Gender categorical
    Units: Subjects
        Female
    37 38 75
        Male
    154 150 304

    End points

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    End points reporting groups
    Reporting group title
    intervention
    Reporting group description
    3 μg/kg of intravenous clonidine - around 20 min before the end of surgery.

    Reporting group title
    placebo
    Reporting group description
    equal quantity of intravenous isotonic saline - around 20 min before completion of surgery

    Subject analysis set title
    Postoperative agitation
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Nine were excluded from the primary outcome analysis because of missing data points.

    Primary: Postoperative agitation

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    End point title
    Postoperative agitation
    End point description
    A Watcha score of more than 2 was considered as postoperative agitation.
    End point type
    Primary
    End point timeframe
    measured every 15 min in the POCU
    End point values
    intervention placebo
    Number of subjects analysed
    187
    183
    Units: Watcha score
        agitation
    46
    86
    Statistical analysis title
    intention-to-treat
    Statistical analysis description
    The proportion of patients with one or more incidence of agitation measured on the Watcha-Scale (scores 3 or 4).
    Comparison groups
    placebo v intervention
    Number of subjects included in analysis
    370
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    generalised linear models (GLM)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    until discharge
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    intervention
    Reporting group description
    3 μg/kg of intravenous clonidine - around 20 min before the end of surgery.

    Reporting group title
    placebo
    Reporting group description
    equal quantity of intravenous isotonic saline - around 20 min before completion of surgery

    Serious adverse events
    intervention placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 191 (1.05%)
    2 / 188 (1.06%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    General disorders and administration site conditions
    events leading to admission
         subjects affected / exposed
    2 / 191 (1.05%)
    2 / 188 (1.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    intervention placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 191 (0.00%)
    5 / 188 (2.66%)
    General disorders and administration site conditions
    div
    Additional description: Opioid-related side-effects Laryngeal spasm Prolonged anaesthesia
         subjects affected / exposed
    0 / 191 (0.00%)
    5 / 188 (2.66%)
         occurrences all number
    0
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2015
    We increased the number of participants from 304 to 380.

    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

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30169192
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