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    Clinical Trial Results:
    Posttonsillectomy peritonsillar bupivacaine infiltration for pain relief in children.

    Summary
    EudraCT number
    		 2011-005467-25
    Trial protocol
    		 BE  
    Global end of trial date
    30 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Dec 2019
    First version publication date
    30 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AT10-2011
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals Leuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium,
    Public contact
    Anesthesia Research, University Hospitals Leuven, +32 16344620, christel.huygens@uzleuven.be
    Scientific contact
    Anesthesia Research, University Hospitals Leuven, +32 16344620, christel.huygens@uzleuven.be
    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
    25 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the proportion of patients who receive piritramide IV the first six hours after the surgery.
    Protection of trial subjects
    All patients received prophylactic pain therapy consisting of paracetamol and ketorolac. Pain scores were measured frequently. Adverse events were evaluated untill 14 days postoperatively
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2012
    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
    Belgium: 200
    Worldwide total number of subjects
    200
    EEA total number of subjects
    200
    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)
    200
    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
    		 Children between 4-10years old undergoing adenotonsillectmy in the day care centre of UZ Leuven

    Pre-assignment
    Screening details
    		 In this prospective double-blind randomized controlled trial we included 200 children, ASA status 1 en 2 undergoing elective adeno-tonsillectomy in an ambulatory setting

    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, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tramadol
    Arm description
    		 Patients allocated to the tramadol group received a bolus of 3 mg/kg tramadol IV intraoperatively
    Arm type
    		 Experimental

    Investigational medicinal product name
    tramadol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    3 mg/kg tramadol diluted in saline to a total volume of 5 ml, injected intravenously as a bolus

    Arm title
    		 Local infiltration analgesia
    Arm description
    		 At the end of surgery the tonsllar loge was infiltrated with bupivacaine 0.25% 5 ml
    Arm type
    		 Experimental

    Investigational medicinal product name
    bupivacaine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Infiltration
    Dosage and administration details
    Infiltration of bupivacaine 0.25% 5 ml

    Number of subjects in period 1
    		Tramadol Local infiltration analgesia
    Started
    100
    100
    Completed
    100
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tramadol
    Reporting group description
    		 Patients allocated to the tramadol group received a bolus of 3 mg/kg tramadol IV intraoperatively

    Reporting group title
    Local infiltration analgesia
    Reporting group description
    		 At the end of surgery the tonsllar loge was infiltrated with bupivacaine 0.25% 5 ml

    Reporting group values
    		 Tramadol Local infiltration analgesia Total
    Number of subjects
    		 100 100 200
    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))
    		 5 (4 to 6) 5 (4 to 7) -
    Gender categorical
    Units: Subjects
        Female
    		 42 48 90
        Male
    		 58 52 110
    ASA
    Units: Subjects
        ASA 1
    		 93 94 187
        ASA 2
    		 7 6 13
    weight
    Units: kilograms
        median (inter-quartile range (Q1-Q3))
    		 19 (17 to 21.5) 20.5 (17.1 to 25) -

    End points

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    End points reporting groups
    Reporting group title
    Tramadol
    Reporting group description
    		 Patients allocated to the tramadol group received a bolus of 3 mg/kg tramadol IV intraoperatively

    Reporting group title
    Local infiltration analgesia
    Reporting group description
    		 At the end of surgery the tonsllar loge was infiltrated with bupivacaine 0.25% 5 ml

    Primary: Number of patients needing piritramide postoperatively

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    End point title
    		 Number of patients needing piritramide postoperatively
    End point description
    End point type
    Primary
    End point timeframe
    Postoperatively in the DSU untill 24 hours postoperatively at home
    End point values
    		 Tramadol Local infiltration analgesia
    Number of subjects analysed
    100
    100
    Units: number
        piritramide
    57
    81
    Statistical analysis title
    		 need for piritramide postoperatively
    Comparison groups
    Tramadol v Local infiltration analgesia
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    POstoperatively in the day care unit, until 2 weeks postoperatively
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Tramadol
    Reporting group description
    		 -

    Reporting group title
    Local infiltrationanalgesia
    Reporting group description
    		 -

    Serious adverse events
    		 Tramadol Local infiltrationanalgesia
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Tramadol Local infiltrationanalgesia
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 100 (8.00%)
    6 / 100 (6.00%)
    Surgical and medical procedures
    post tonsillectomy hemorrage
         subjects affected / exposed
    8 / 100 (8.00%)
    6 / 100 (6.00%)
         occurrences all number
    8
    6

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30640245
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