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    Clinical Trial Results:
    Double-blind randomized clinical trial to compare presurgery anxiolysis in children treated with hydroxyzine versus non-pharmacological intervention (distractoria technique clown).

    Summary
    EudraCT number
    		 2016-002890-37
    Trial protocol
    		 ES  
    Global end of trial date
    21 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2022
    First version publication date
    25 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03324828
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Esther Aleo Lujan
    Sponsor organisation address
    profesor martin lagos s/n, Madrid, Spain, 28040
    Public contact
    Servicio de Pediatría Hospital Clinico San Carlos, Esther Aleo Lujan, +34 913303000, fibucicec.hcsc@salud.madrid.org
    Scientific contact
    Servicio de Pediatría Hospital Clinico San Carlos, Esther Aleo Lujan, +34 913303000, fibucicec.hcsc@salud.madrid.org
    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
    31 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether the association of pharmacological measures (hydroxyzine) and not pharmacological (distraction by clowns) decreases preoperative anxiety (POA) for children who will be undergoing outpatient surgery.
    Protection of trial subjects
    The study was approved by the Clinical Research Ethics Committee of the hospital. The confidentiality of subject data was always maintained in accordance with current legislation. Written informed consent was obtained before any intervention from all subjects, legal surrogates, parents, or legal guardians for minor subjects. This study was carried out following international ethical recommendations for conducting human research and clinical trials contained in the latest revision of the Declaration of Helsinki as well as those established in the Good Clinical Practice Guidelines and current legislation. All subjects were supervised by qualified medical personnel during their participation in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Oct 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 165
    Worldwide total number of subjects
    165
    EEA total number of subjects
    165
    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)
    128
    Adolescents (12-17 years)
    37
    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
    		 -

    Pre-assignment
    Screening details
    		 We studied 165 patients with ages between 2 and 16 years (mean 7.4, SD 4.2). 127 were boys, and 41 were girls. The declaration of the COVID-19 global pandemic forced the premature ending of the study, and thus, the objective sample size was only reached in groups 1 (hydroxyzine) and 2 (placebo).

    Period 1
    Period 1 title
    Time-Point 0 (M0) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 Pharmacological intervention (oral hydroxyzine 2 mg/kg masked with 5 ml of juice, administered at least 30 min prior to surgery) plus standard management consisting of parental accompaniment during the preoperative period, postanesthesia recovery area, and up to hospital discharge
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Hidroxicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    mg/kg masked with 5 ml of juice, administered at least 30 min prior to surgery

    Arm title
    		 Group 2
    Arm description
    		 Standard management
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Group 3
    Arm description
    		 Standard management + Dr. Sonrisas + oral hydroxyzine
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hidroxicine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    2 mg/kg masked with 5 ml of juice, administered at least 30 min prior to surgery

    Arm title
    		 Group 4
    Arm description
    		 Standard management + Dr. Sonrisas
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placevo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    5 ml of juice, administered at least 30 min prior to surgery

    Number of subjects in period 1
    		Group 1 Group 2 Group 3 Group 4
    Started
    59
    52
    25
    29
    Completed
    53
    48
    24
    27
    Not completed
    6
    4
    1
    2
         Screening failure
    3
    3
    -
    2
         Consent withdrawn by subject
    1
    -
    -
    -
         Lost to follow-up
    1
    1
    -
    -
         discontinuation
    1
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Pharmacological intervention (oral hydroxyzine 2 mg/kg masked with 5 ml of juice, administered at least 30 min prior to surgery) plus standard management consisting of parental accompaniment during the preoperative period, postanesthesia recovery area, and up to hospital discharge

    Reporting group title
    Group 2
    Reporting group description
    		 Standard management

    Reporting group title
    Group 3
    Reporting group description
    		 Standard management + Dr. Sonrisas + oral hydroxyzine

    Reporting group title
    Group 4
    Reporting group description
    		 Standard management + Dr. Sonrisas

    Reporting group values
    		 Group 1 Group 2 Group 3 Group 4 Total
    Number of subjects
    		 59 52 25 29 165
    Age categorical
    Age (years) Mean ± SD∗
    Units: Subjects
        Children (2-11 years)
    		 46 41 19 22 128
        Adolescents (12-17 years)
    		 13 11 6 7 37
    Age continuous
    Age (years) Mean ± SD∗
    Units: years
        arithmetic mean (standard deviation)
    		 7.7 ( 4.1 ) 8.0 ( 4.3 ) 7.7 ( 4.1 ) 6.4 ( 3.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 53 40 19 21 133
        Male
    		 6 12 6 8 32

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 Pharmacological intervention (oral hydroxyzine 2 mg/kg masked with 5 ml of juice, administered at least 30 min prior to surgery) plus standard management consisting of parental accompaniment during the preoperative period, postanesthesia recovery area, and up to hospital discharge

    Reporting group title
    Group 2
    Reporting group description
    		 Standard management

    Reporting group title
    Group 3
    Reporting group description
    		 Standard management + Dr. Sonrisas + oral hydroxyzine

    Reporting group title
    Group 4
    Reporting group description
    		 Standard management + Dr. Sonrisas

    Primary: m-YPAS at the time of anaesthetic induction

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    End point title
    		 m-YPAS at the time of anaesthetic induction
    End point description
    End point type
    Primary
    End point timeframe
    M3: at the time of anaesthetic induction
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    53
    48
    24
    27
    Units: m-YPAS scale
        geometric mean (standard deviation)
    39.2 ( 27.9 )
    37 ( 26.1 )
    34.7 ( 25.5 )
    32.4 ( 20.5 )
    Statistical analysis title
    		 ANOVA
    Comparison groups
    Group 1 v Group 2 v Group 3 v Group 4
    Number of subjects included in analysis
    152
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    P-value
    		 ≤ 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: ICC values

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    End point title
    		 ICC values
    End point description
    End point type
    Secondary
    End point timeframe
    M3: at the time of anaesthetic induction
    End point values
    		 Group 1 Group 2 Group 3 Group 4
    Number of subjects analysed
    53
    48
    24
    27
    Units: ICC values
        geometric mean (standard deviation)
    1.8 ( 3.4 )
    1.5 ( 3 )
    1.2 ( 2.4 )
    1.5 ( 3.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    throughout the study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There are no non-serious adverse events recorded for these results.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Aug 2017
    Elimination STAI/SCAP anxiety scale. Exclusion criteria actualization.
    01 Nov 2017
    Selection Criteria actualization.
    12 Dec 2017
    Criteria selection actualization
    10 Aug 2018
    Data proteccion actualization
    10 Apr 2019
    Inclusion an analysis of ACTH and cortisol level

    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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