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    Clinical Trial Results:
    Pain relief of methoxyflurane in patients with burns

    Summary
    EudraCT number
    		 2020-005865-14
    Trial protocol
    		 DK  
    Global end of trial date
    29 Aug 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Sep 2022
    First version publication date
    16 Sep 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2020110357
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Rigshospitalet
    Sponsor organisation address
    Inge Lehmanns Vej 6, Copenhagen, Denmark, DK-2100
    Public contact
    Dept Anaesthesia, Rigshospitalet, 45 35458043, lars.rasmussen.01@regionh.dk
    Scientific contact
    Dept Anaesthesia, Rigshospitalet, 61652212 35458043, lars.rasmussen.01@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
    29 Aug 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess pain relief of methoxyflurane in patients with burns undergoing change of wound dressing
    Protection of trial subjects
    Basic pain relief provided
    Background therapy
    		 Paracetamol, NSAID and opiods provided for basic pain relief
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    25 Jun 2021
    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: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    8
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was undertaken at Copenhagen University Hospital, Rigshospitalet, 25th of June 2021 to 31st of July 2022

    Pre-assignment
    Screening details
    		 We screened burn patients at least 18 years and able to give informed consent.

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Arm title
    		 Methoxyflurane
    Arm description
    		 Burn patients receiving methoxyflurane
    Arm type
    		 Experimental

    Investigational medicinal product name
    Penthrox
    Investigational medicinal product code
    PR1
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Self administered inhalation through specific device containing 3 ml

    Number of subjects in period 1
    		Methoxyflurane
    Started
    12
    Completed
    12

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 12 12
    Age categorical
    Age
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Below 65
    		 0 0
        Adult
    		 8 8
        Old
    		 4 4
    Age continuous
    Age
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 56 (50 to 68) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    All
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients

    Subject analysis sets values
    		 All
    Number of subjects
    12
    Age categorical
    Age
    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
        Below 65
    0
        Adult
    8
        Old
    4
    Age continuous
    Age
    Units: years
        median (inter-quartile range (Q1-Q3))
    56 (50 to 68)
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Methoxyflurane
    Reporting group description
    		 Burn patients receiving methoxyflurane

    Subject analysis set title
    All
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients

    Primary: Maximal pain during the procedure

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    End point title
    		 Maximal pain during the procedure [1]
    End point description
    Maximal pain as expressed by patient
    End point type
    Primary
    End point timeframe
    During procedure with change of dressing
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No test done
    End point values
    		 All
    Number of subjects analysed
    12
    Units: mm
        median (inter-quartile range (Q1-Q3))
    60 (37 to 80)
    No statistical analyses for this end point

    Secondary: Patient satisfaction

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    End point title
    		 Patient satisfaction
    End point description
    End point type
    Secondary
    End point timeframe
    After procedure
    End point values
    		 All
    Number of subjects analysed
    12
    Units: mm
        median (inter-quartile range (Q1-Q3))
    96 (69 to 100)
    No statistical analyses for this end point

    Secondary: Nurse's assessment of pain

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    End point title
    		 Nurse's assessment of pain
    End point description
    End point type
    Secondary
    End point timeframe
    After procedure
    End point values
    		 All
    Number of subjects analysed
    12
    Units: mm
        median (inter-quartile range (Q1-Q3))
    57 (28 to 67)
    No statistical analyses for this end point

    Secondary: Oxygen saturation

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    End point title
    		 Oxygen saturation
    End point description
    End point type
    Secondary
    End point timeframe
    Lowest during procedure
    End point values
    		 All
    Number of subjects analysed
    12
    Units: Per cent
        median (inter-quartile range (Q1-Q3))
    96 (94 to 98)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Seven days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2022AA
    Reporting groups
    Reporting group title
    All exposed
    Reporting group description
    		 Burn patients exposed to methoxyflurane

    Serious adverse events
    		 All exposed
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 All exposed
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    Gastrointestinal disorders
    Nausea
    Additional description: nausea experienced after the procedure
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    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.
    Slow recruitment
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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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