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    Clinical Trial Results:
    Paramedic Analgesia Comparing Ketamine and MorphiNe in trauma

    Summary
    EudraCT number
    		 2020-000154-10
    Trial protocol
    		 GB  
    Global end of trial date
    14 Feb 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Mar 2025
    First version publication date
    02 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SOC.12/19-20
    Additional study identifiers
    ISRCTN number
    		 ISRCTN14124474
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Warwick
    Sponsor organisation address
    Gibbett Hill Road, Coventry, United Kingdom, CV4 7AL
    Public contact
    Trial Manager, University of Warwick Clinical Trials Unit, 0247 6150478, packman@warwick.ac.uk
    Scientific contact
    Dr Michael Smyth, University of Warwick Clinical Trials Unit, 0247 6150478, packman@warwick.ac.uk
    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
    14 May 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Nov 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial is to determine whether paramedic administered ketamine or morphine provides more effective pain relief for patients reporting severe pain following trauma. This will be measured by using a 0-10 numeric rating scale and the Sum of Pain Intensity Difference (SPID).
    Protection of trial subjects
    Procedures for emergency unblinding. procedures in place to treat any distressing side effects e.g. abnormal behavioural reactions. Options for rescue analgesia in the event trial analgesia was ineffective. procedures in place for cases of accidental overdose procedures in place for addressing non-disclosed pregnancy
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Oct 2021
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 449
    Worldwide total number of subjects
    449
    EEA total number of subjects
    0
    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)
    1
    Adults (18-64 years)
    202
    From 65 to 84 years
    155
    85 years and over
    91

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Patients were eligible for inclusion if they had suffered an acute traumatic injury, were at least 16 years of age or over, reported a pain score of 7 or greater on a 0-10 numeric rating score (NRS) and, in the opinion of the attending paramedic, would normally require parenteral morphine for analgesia.

    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
    Blinding implementation details
    Treatment packs were manufactured and supplied by an appropriately licenced pharmaceutical company. Treatment packs, containing either ketamine or morphine, were identical in appearance, apart from their unique sequential number. Packs were distributed by the trial drug manufacturer to ensure equal proportions across participating sites. Individual participant randomisation occurred when the attending paramedic opened the trial treatment pack.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 morphine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    morphine sulphate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraosseous use, Intravenous use
    Dosage and administration details
    titrate to effect. maximum cummulative dose 20mg

    Investigational medicinal product name
    ketamine hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraosseous use, Intravenous use
    Dosage and administration details
    titrate to effect. maximum cummulative dose 30mg

    Arm title
    		 ketamine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ketamine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraosseous use, Intravenous use
    Dosage and administration details
    Titrate to effect. Maximum cummulative dose 30mg.

    Number of subjects in period 1
    		morphine ketamine
    Started
    230
    219
    Completed
    230
    219

    Baseline characteristics

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

    Reporting group title
    ketamine
    Reporting group description
    		 -

    Reporting group values
    		 morphine ketamine Total
    Number of subjects
    		 230 219 449
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ( 22.1 ) 64.0 ( 21.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 124 117 241
        Male
    		 106 102 208

    End points

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

    Reporting group title
    ketamine
    Reporting group description
    		 -

    Primary: SPID score

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    End point title
    		 SPID score
    End point description
    End point type
    Primary
    End point timeframe
    time from first drug administration to arrival at hospital
    End point values
    		 morphine ketamine
    Number of subjects analysed
    230
    219
    Units: number
        arithmetic mean (standard deviation)
    3.4 ( 3.0 )
    3.5 ( 2.8 )
    Statistical analysis title
    		 Adjusted estimate
    Comparison groups
    morphine v ketamine
    Number of subjects included in analysis
    449
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7
    Method
    		 Regression, Linear
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.43
         upper limit
    		 0.64

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from administration of drug to 6 months post administration
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    5
    Reporting groups
    Reporting group title
    morphine
    Reporting group description
    		 -

    Reporting group title
    ketamine
    Reporting group description
    		 -

    Serious adverse events
    		 morphine ketamine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 230 (1.74%)
    8 / 219 (3.65%)
         number of deaths (all causes)
    10
    14
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Immediately life threatening problem
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 219 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 10
    0 / 14
    Prolonged hospitalisation
         subjects affected / exposed
    1 / 230 (0.43%)
    1 / 219 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 230 (0.87%)
    2 / 219 (0.91%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 10
    0 / 14
    Required medical intervention
         subjects affected / exposed
    4 / 230 (1.74%)
    1 / 219 (0.46%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.5%
    Non-serious adverse events
    		 morphine ketamine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    174 / 230 (75.65%)
    143 / 219 (65.30%)
    Injury, poisoning and procedural complications
    Other
    Additional description: any non-serious adverse event not categorised as airway, respiratory, cardiovascular or nervous
         subjects affected / exposed
    57 / 230 (24.78%)
    44 / 219 (20.09%)
         occurrences all number
    57
    44
    Cardiac disorders
    Hypotension
    Additional description: hypotension
         subjects affected / exposed
    34 / 230 (14.78%)
    26 / 219 (11.87%)
         occurrences all number
    34
    26
    Nervous system disorders
    Nervous system disorder
    Additional description: altered consciousness or acute behavioural disturbance
         subjects affected / exposed
    18 / 230 (7.83%)
    42 / 219 (19.18%)
         occurrences all number
    18
    42
    Respiratory, thoracic and mediastinal disorders
    Airway
    Additional description: need for any airway intervention e.g. positioning to ensure open airway, airway adjunct, suction
         subjects affected / exposed
    27 / 230 (11.74%)
    16 / 219 (7.31%)
         occurrences all number
    27
    16
    Hypoxia
    Additional description: need for supplemental oxygen or assisted ventilation
         subjects affected / exposed
    38 / 230 (16.52%)
    15 / 219 (6.85%)
         occurrences all number
    38
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2020
    Update to investigational medicinal product description to permit intraosseous administration
    14 Apr 2021
    Update to include risk assessment for concomitant use of a COVID-19 vaccine
    23 Jun 2021
    Revision to consent process. New and revised letters and consent forms
    30 Jun 2021
    Protocol amendment to correct dosing table. Minor update to eConsent forms
    25 Oct 2021
    Change of PI at Yorkshire site
    05 May 2022
    Update exclusion criteria and participant information sheet PIS
    04 Oct 2022
    Extension of trial recruitment whilst pending official extension.
    15 Dec 2022
    Extension of PACKMaN trial.
    04 Oct 2023
    Protocol amendment to update unblinding process and results letter for participants. Addition of final results letter for patients.
    25 Oct 2023
    Addition of participant unblinding letter
    17 Nov 2023
    Protocol amendment to update names of TSC PPI members
    25 Jan 2024
    Protocol amendment to provide clarity on who the hospital data collection form will be collected from and data retention where only verbal assent is in place.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Nov 2020
    trial paused (before recruitment had commenced) due to cOVID-19 pandemic
    01 Sep 2021

    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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