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    Clinical Trial Results:
    Pain management after operative treatment of extremity fractures, a randomized clinical trial

    Summary
    EudraCT number
    2012-000680-24
    Trial protocol
    NL  
    Global end of trial date
    01 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Jan 2017
    First version publication date
    06 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    POSTrct_ORTGH
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Academisch Medisch Centrum
    Sponsor organisation address
    Meibergdreef 9, Amsterdam, Netherlands,
    Public contact
    P. Kloen, Academisch Medisch Centrum, +31 205663374, p.kloen@amc.uva.nl
    Scientific contact
    P. Kloen, Academisch Medisch Centrum, +31 205663374, p.kloen@amc.uva.nl
    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
    11 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine (differences in) patient satisfaction with pain relief and pain intensity (Numeric Rating Scale).
    Protection of trial subjects
    Escape medication could be provided
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 52
    Worldwide total number of subjects
    52
    EEA total number of subjects
    52
    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)
    45
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited worldwide from July 2012 to March 2015

    Pre-assignment
    Screening details
    Patients were screened after extremity fractures occured

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind [1]
    Roles blinded
    Investigator, Monitor, Carer [2]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Acetaminophen
    Arm description
    Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours
    Arm type
    Active comparator

    Investigational medicinal product name
    acetaminophen
    Investigational medicinal product code
    Other name
    Paracetamol
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1000mg every 6 hours

    Arm title
    Tramadol
    Arm description
    Patients received a prescription for tramadol 50mg every 8 hours as needed
    Arm type
    Active comparator

    Investigational medicinal product name
    Tramadol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg every 8 hours as needed

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Only subjects were not blinded
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: No blinding of subjects
    Number of subjects in period 1
    Acetaminophen Tramadol
    Started
    27
    25
    Completed
    25
    14
    Not completed
    2
    11
         No step 2 medication taken
             -
             9
         Lost to follow-up
             2
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Acetaminophen
    Reporting group description
    Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours

    Reporting group title
    Tramadol
    Reporting group description
    Patients received a prescription for tramadol 50mg every 8 hours as needed

    Reporting group values
    Acetaminophen Tramadol Total
    Number of subjects
    27 25 52
    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
        log mean (standard deviation)
    45 ± 18 42 ± 19 -
    Gender categorical
    Units: Subjects
        Female
    14 10 24
        Male
    13 15 28
    Pain at this moment
    Units: 11
        median (inter-quartile range (Q1-Q3))
    3 (1 to 5.3) 3 (1 to 6) -
    Worst pain
    Units: 11
        median (inter-quartile range (Q1-Q3))
    6 (3 to 8) 5 (4 to 7.8) -
    Average pain
    Units: 11
        median (inter-quartile range (Q1-Q3))
    4.5 (3 to 5) 3.5 (2 to 5) -
    Expected pain intensity
    Units: 11
        median (inter-quartile range (Q1-Q3))
    4 (2.8 to 5) 4 (3 to 5.5) -

    End points

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    End points reporting groups
    Reporting group title
    Acetaminophen
    Reporting group description
    Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours

    Reporting group title
    Tramadol
    Reporting group description
    Patients received a prescription for tramadol 50mg every 8 hours as needed

    Primary: Satisfaction after pain relief

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    End point title
    Satisfaction after pain relief
    End point description
    End point type
    Primary
    End point timeframe
    2 weeks post-operative
    End point values
    Acetaminophen Tramadol
    Number of subjects analysed
    27
    25
    Units: Numeric rating scale
        number (not applicable)
    8.3
    8.5
    Statistical analysis title
    Non-inferiority
    Statistical analysis description
    Non-inferiority
    Comparison groups
    Tramadol v Acetaminophen
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    < 0.05
    Method
    Chi-squared
    Parameter type
    Mean difference (final values)
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.78
         upper limit
    1.3
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    2 weeks post-operative
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Acetaminophen
    Reporting group description
    Patients received a prescription for acetaminophen with a maximum dose of 1000mg every 6 hours

    Reporting group title
    Tramadol
    Reporting group description
    Patients received a prescription for tramadol 50mg every 8 hours as needed

    Serious adverse events
    Acetaminophen Tramadol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 14 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Acetaminophen Tramadol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    10 / 14 (71.43%)
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 25 (0.00%)
    10 / 14 (71.43%)
         occurrences all number
    0
    10

    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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