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    Clinical Trial Results:
    Comparison of the effect of xylometazoline and cocaine on epistaxis when administered as local vasoconstrictors prior to nasal intubation

    Summary
    EudraCT number
    		 2021-000691-11
    Trial protocol
    		 DK  
    Global end of trial date
    22 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2024
    First version publication date
    16 Oct 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    89303200
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05334017
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Blegdamsvej 3, Copenhagen, Denmark,
    Public contact
    Department of Anesthesiology, Rigshospitalet, Centre of Head and Orthopaedics, +45 35453474, anop-hoc.rigshospitalet@regionh.dk
    Scientific contact
    Department of Anesthesiology, Rigshospitalet, Centre of Head and Orthopaedics, +45 35453474, anop-hoc.rigshospitalet@regionh.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
    15 Aug 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to compare xylometazoline and cocaine’s effect on minimizing epistaxis when administered as a local vasoconstrictor prior to nasal intubation.
    Protection of trial subjects
    Covered by the Danish 'Patienterstatning'
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Sep 2022
    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
    Denmark: 119
    Worldwide total number of subjects
    119
    EEA total number of subjects
    119
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    110
    From 65 to 84 years
    8
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Assessed for eligibility (n=275) Excluded (n=155) No investigator available (n=124) Declined to participate (n=24) Previously included (n=3) Randomization module unavailable (n=3) Active cocaine abuse (n=1) Enrolled (n=120) Excluded prior to randomization du to change of intubation method (n=1) Randomized (n=119)

    Pre-assignment period milestones
    Number of subjects started
    		 119
    Number of subjects completed
    		 119

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cocaine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cocaine 4%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    2 mL 4% nasal spray through diffuser

    Arm title
    		 Xylometazoline
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Xylometazoline
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    2 mL 0.05% xylometazoline as nasal spray through diffuser

    Number of subjects in period 1
    		Cocaine Xylometazoline
    Started
    60
    59
    Completed
    60
    59

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cocaine
    Reporting group description
    		 -

    Reporting group title
    Xylometazoline
    Reporting group description
    		 -

    Reporting group values
    		 Cocaine Xylometazoline Total
    Number of subjects
    		 60 59 119
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 27 (23 to 40) 24 (22 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 31 36 67
        Male
    		 29 23 52

    End points

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    End points reporting groups
    Reporting group title
    Cocaine
    Reporting group description
    		 -

    Reporting group title
    Xylometazoline
    Reporting group description
    		 -

    Primary: Epistaxis

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    End point title
    		 Epistaxis
    End point description
    End point type
    Primary
    End point timeframe
    Immediately after nasotracheal intubation
    End point values
    		 Cocaine Xylometazoline
    Number of subjects analysed
    53
    49
    Units: Yes/no
    32
    34
    Statistical analysis title
    		 Fisher's exact test
    Comparison groups
    Cocaine v Xylometazoline
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 hours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 GCP
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Cocaine
    Reporting group description
    		 -

    Reporting group title
    Xylometazoline
    Reporting group description
    		 -

    Serious adverse events
    		 Cocaine Xylometazoline
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Desaturation
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 59 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Cocaine Xylometazoline
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 60 (16.67%)
    14 / 59 (23.73%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 60 (16.67%)
    14 / 59 (23.73%)
         occurrences all number
    10
    14

    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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