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    Clinical Trial Results:
    Pharmacokinetic study of the opioid ketobemidone in neonates after an intravenous administration

    Summary
    EudraCT number
    		 2008-008012-98
    Trial protocol
    		 SE  
    Global end of trial date
    25 Mar 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2020
    First version publication date
    12 Feb 2020
    Other versions
    Summary report(s)
    		 Pharmacokinetics after a single dose of the opioid ketobemidone in neonates

    Trial information

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    Trial identification
    Sponsor protocol code
    sl2008-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Stockholms Läns Landsting
    Sponsor organisation address
    Karolinska University Hospital, Stockholm, Sweden, 17176
    Public contact
    Stefan Lundeberg, Karolinska University Hospital, +46 851777189, stefan.lundeberg@sll.se
    Scientific contact
    Stefan Lundeberg, Karolinska University Hospital, +46 851777189, stefan.lundeberg@sll.se
    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 Apr 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Apr 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determination of pharmacokinetic parameters of ketobemidone after an intravenous injection
    Protection of trial subjects
    Bloodsamples taken from an indwelling catheter which was used for the postoperative care.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Aug 2010
    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
    Sweden: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    15
    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 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Neonates scheduled for elective surgery.Consent given by care givers

    Pre-assignment
    Screening details
    		 16 patients were screened. In one case no consent was given.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Patients recruited and after consent given the drug ketobemidone during surgery. Blood samples were taken för concentration analysis of ketobemidone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ketobemidone hydrochloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    0.05 mg/kg of ketobemidone, intravenous injektion during anesthesia

    Number of subjects in period 1
    		Single arm
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 Newborns receiving ketobemidone iv as a single dose

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 15 15
    Age categorical
    Newborns
    Units: Subjects
        Newborns
    		 15 15
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 7 7
    Age
    Newborns
    Units: Subjects
        Newborns
    		 15 15
    Subject analysis sets

    Subject analysis set title
    Pharmacokinetics
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pharmacokinetics after a single dose of ketobemidone in neonates. Plasma concentration

    Subject analysis sets values
    		 Pharmacokinetics
    Number of subjects
    15
    Age categorical
    Newborns
    Units: Subjects
        Newborns
    15
    Age continuous
    Neonates
    Units: days
        median (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
        Male
    Age
    Newborns
    Units: Subjects
        Newborns
    15

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Patients recruited and after consent given the drug ketobemidone during surgery. Blood samples were taken för concentration analysis of ketobemidone.

    Subject analysis set title
    Pharmacokinetics
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pharmacokinetics after a single dose of ketobemidone in neonates. Plasma concentration

    Primary: Pharmacokinetic

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    End point title
    		 Pharmacokinetic
    End point description
    End point type
    Primary
    End point timeframe
    When all blood samples had been analysed and pharmacokinetic parameters had been calculated
    End point values
    		 Single arm Pharmacokinetics
    Number of subjects analysed
    15
    15
    Units: ng/ml
        number (not applicable)
    15
    15
    Statistical analysis title
    		 Descriptive
    Statistical analysis description
    Measure of plasma concentration and pharmacokinetic parameters.
    Comparison groups
    Single arm v Pharmacokinetics
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.05 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - Concentration in plasma, calculations median and range values for different parameters
    [2] - not applicable

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Until 48 hours after last blood sample
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Local protocol
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Ketobemidone neonates
    Reporting group description
    		 -

    Serious adverse events
    		 Ketobemidone neonates
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Ketobemidone neonates
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    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: In this small group of patients receiving the opioid ketobemidone we did not record any non-serious advents. Ketobemidone is used routinely as an analgesic in the postoperative period.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22834454
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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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