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    Clinical Trial Results:
    Comparative Prospective Randomized Study in Postoperative Cardiac Surgery Patients on Analgesia with Morphine Continuous Infusion or Sublingual Sufentanil (Zalviso®).

    Summary
    EudraCT number
    		 2017-004038-28
    Trial protocol
    		 BE  
    Global end of trial date
    06 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2025
    First version publication date
    09 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Zalviso
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZ Brussel
    Sponsor organisation address
    Laarbeeklaan, Brussel, Belgium,
    Public contact
    Virgini Van Buggenhout, Universitair Ziekenhuis Brussel, +32 24776001, virgini.vanbuggenhout@uzbrussel.be
    Scientific contact
    Virgini Van Buggenhout, Universitair Ziekenhuis Brussel, +32 24776001, virgini.vanbuggenhout@uzbrussel.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
    30 Dec 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The present study aims to assess postoperative pain after cardiac surgery by means of a standardized scoring system.
    Protection of trial subjects
    Patients were followed up during the entire study after informed consent was given. This to assess safety of the IMP used.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Nov 2017
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    59
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 483 [1]
    Number of subjects completed
    		 80

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 not meeting in- and exclusion criteria: 310
    Reason: Number of subjects
    		 not willing to give consent: 93
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 483 patients were scheduled for cardiac surgery between june 2018 and september 2019. However only 80 were eligible of those 483 patients.
    Period 1
    Period 1 title
    study conduct (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 sublingual sufentanil tablet system
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    sufentanil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Sublingual use
    Dosage and administration details
    15-microgram sublingual sufentanil tablet with a 20-minute lag time between each dose

    Arm title
    		 continuous morphine pump
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    morphine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    continuous mrophine pump: 0.1 mg/kg/dose

    Number of subjects in period 1
    		sublingual sufentanil tablet system continuous morphine pump
    Started
    40
    40
    Completed
    31
    33
    Not completed
    9
    7
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    3
    3
         Lost to follow-up
    -
    2
         did not receive assigned treatment
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    sublingual sufentanil tablet system
    Reporting group description
    		 -

    Reporting group title
    continuous morphine pump
    Reporting group description
    		 -

    Reporting group values
    		 sublingual sufentanil tablet system continuous morphine pump Total
    Number of subjects
    		 40 40 80
    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
        arithmetic mean (standard deviation)
    		 64.2 ( 7.2 ) 64 ( 10.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 8 13
        Male
    		 35 32 67
    length
    Units: centimetre
        arithmetic mean (standard deviation)
    		 172.1 ( 6.8 ) 172.9 ( 8.6 ) -
    weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 84.9 ( 12.5 ) 80.7 ( 16.3 ) -
    BMI
    Units: kilogram(s)/square metre
        arithmetic mean (standard deviation)
    		 28.7 ( 3.4 ) 26.9 ( 4.2 ) -
    total dose of sufentanil
    Units: microgram(s)
        arithmetic mean (standard deviation)
    		 97.8 ( 55.8 ) 97.9 ( 39.4 ) -
    duration until extubation after ICU arrival
    Units: hour
        arithmetic mean (standard deviation)
    		 5.3 ( 2.8 ) 5.1 ( 4.5 ) -

    End points

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    End points reporting groups
    Reporting group title
    sublingual sufentanil tablet system
    Reporting group description
    		 -

    Reporting group title
    continuous morphine pump
    Reporting group description
    		 -

    Primary: cumulative pain score 24hrs after extubation

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    End point title
    		 cumulative pain score 24hrs after extubation
    End point description
    End point type
    Primary
    End point timeframe
    24hrs after extubation
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    1.3 ( 0.8 )
    0.8 ( 0.7 )
    Statistical analysis title
    		 chi square test
    Comparison groups
    continuous morphine pump v sublingual sufentanil tablet system
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: cumulative pain score 48hrs after extubation

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    End point title
    		 cumulative pain score 48hrs after extubation
    End point description
    End point type
    Primary
    End point timeframe
    pain score 48 hours after extubation
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    0.6 ( 0.5 )
    0.2 ( 0.3 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: cumulative pain score 63 hrs after extubation

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    End point title
    		 cumulative pain score 63 hrs after extubation
    End point description
    End point type
    Primary
    End point timeframe
    pain score 63 hours after extubation
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    0.1 ( 0.2 )
    0.0 ( 0.0 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 4

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    End point title
    		 pain score hour 4
    End point description
    End point type
    Primary
    End point timeframe
    pain score on hour 4 between extubation and discharge of ICU
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    2.4 ( 1.8 )
    1.1 ( 1.9 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 11

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    End point title
    		 pain score hour 11
    End point description
    End point type
    Primary
    End point timeframe
    pain score 11 hours after extubation and still in ICU
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    2.1 ( 2.1 )
    0.2 ( 0.6 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 12

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    End point title
    		 pain score hour 12
    End point description
    End point type
    Primary
    End point timeframe
    pain score 12 hours after extubation and patient still on ICU
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    2.2 ( 2.2 )
    1.0 ( 1.8 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 16

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    End point title
    		 pain score hour 16
    End point description
    End point type
    Primary
    End point timeframe
    pain score 16 hours after extubation and still on ICU
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    2.3 ( 2.2 )
    0.6 ( 1.0 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 20

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    End point title
    		 pain score hour 20
    End point description
    End point type
    Primary
    End point timeframe
    pain score 20 hrs after extubation and still on ICU
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    1.6 ( 2.2 )
    0.4 ( 0.8 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 46

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    End point title
    		 pain score hour 46
    End point description
    End point type
    Primary
    End point timeframe
    pain score 46 hours after extubation and still on ICU ward
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    1.9 ( 1.7 )
    0 ( 0 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: pain score hour 17

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    End point title
    		 pain score hour 17
    End point description
    End point type
    Primary
    End point timeframe
    pain score 17 hours after extubation and still on ICU ward
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: pain score
        arithmetic mean (standard deviation)
    2.4 ( 2.3 )
    0.6 ( 1.1 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Primary: RASS POD 1 20:00

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    End point title
    		 RASS POD 1 20:00
    End point description
    End point type
    Primary
    End point timeframe
    Richmond agitation-sedation scale post operative day 1 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    0 ( 0.26 )
    0.03 ( 0.17 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: cumulative opioid dose

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    End point title
    		 cumulative opioid dose
    End point description
    End point type
    Secondary
    End point timeframe
    in milligrams intravenous morphine equivalents
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: milligram(s)
        arithmetic mean (standard deviation)
    39.84 ( 21.96 )
    241.94 ( 218.73 )
    Statistical analysis title
    		 chi square
    Comparison groups
    continuous morphine pump v sublingual sufentanil tablet system
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Incidence of PONV

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    End point title
    		 Incidence of PONV
    End point description
    End point type
    Secondary
    End point timeframe
    incindence of postoperative nausea and vomiting during study conduct
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: incidence of PONV
    10
    14
    No statistical analyses for this end point

    Secondary: incidence of sedation

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    End point title
    		 incidence of sedation
    End point description
    End point type
    Secondary
    End point timeframe
    incidence of sedation during study conduct
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: incidence of sedation
    2
    1
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RASS POD 1 8:00

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    End point title
    		 RASS POD 1 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    Richmond agitation-sedation scale post operative day 1 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    -0.06 ( 0.44 )
    -0.03 ( 0.47 )
    Statistical analysis title
    		 chi square
    Comparison groups
    continuous morphine pump v sublingual sufentanil tablet system
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RASS POD 2 8:00

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    End point title
    		 RASS POD 2 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    Richmond agitation-sedation scale post operative day 2 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    0.13 ( 0.34 )
    0 ( 0 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RASS POD 2 20:00

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    End point title
    		 RASS POD 2 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    Richmond agitation-sedation scale post operative day 2 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    -0.13 ( 0.72 )
    0.06 ( 0.35 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RASS POD 3 8:00

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    End point title
    		 RASS POD 3 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    Richmond agitation-sedation scale post operative day 3 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    -0.06 ( 0.81 )
    0.03 ( 0.17 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RASS POD3 20:00

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    End point title
    		 RASS POD3 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    Richmond agitation-sedation scale post operative day 3 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: RASS
        arithmetic mean (standard deviation)
    -0.13 ( 0.72 )
    0 ( 0 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD1 8:00

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    End point title
    		 RR POD1 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    mean respiratory rate post operative day 1 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths per minute
        arithmetic mean (standard deviation)
    17 ( 5 )
    18 ( 5 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD 1 20:00

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    End point title
    		 RR POD 1 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    Respiratory rate post operative day 1 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths/minute
        arithmetic mean (standard deviation)
    18 ( 6 )
    18 ( 4 )
    Statistical analysis title
    		 chi square
    Comparison groups
    continuous morphine pump v sublingual sufentanil tablet system
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD 2 8:00

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    End point title
    		 RR POD 2 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    Respiratory rate post operative day 2 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths/minute
        arithmetic mean (standard deviation)
    17 ( 6 )
    20 ( 5 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD 3 8:00

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    End point title
    		 RR POD 3 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    Respiratory rate post operative day 3 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths/minute
        arithmetic mean (standard deviation)
    20 ( 7 )
    19 ( 6 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD 3 20:00

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    End point title
    		 RR POD 3 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    Respiratory rate post operative day 3 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths/minute
        arithmetic mean (standard deviation)
    21 ( 6 )
    21 ( 5 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: RR POD 2 20:00

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    End point title
    		 RR POD 2 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    respiratory rate post operative day 2 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: breaths/minute
        arithmetic mean (standard deviation)
    19 ( 6 )
    20 ( 6 )
    Statistical analysis title
    		 chi square
    Comparison groups
    continuous morphine pump v sublingual sufentanil tablet system
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 1 8:00

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    End point title
    		 HR POD 1 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate post operative day 1 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    79 ( 11 )
    79 ( 13 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 1 20:00

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    End point title
    		 HR POD 1 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate postoperative day 1 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    79 ( 9 )
    83 ( 13 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 2 8:00

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    End point title
    		 HR POD 2 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate postoperative day 2 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    79 ( 12 )
    82 ( 10 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 2 20:00

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    End point title
    		 HR POD 2 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate postoperative day 2 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    78 ( 12 )
    85 ( 18 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 3 8:00

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    End point title
    		 HR POD 3 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate postoperative day 3 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    81 ( 12 )
    83 ( 13 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: HR POD 3 20:00

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    End point title
    		 HR POD 3 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    heart rate postoperative day 3 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: beats/minute
        arithmetic mean (standard deviation)
    84 ( 21 )
    84 ( 17 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 1 8:00

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    End point title
    		 BP POD 1 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 1 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    82 ( 11 )
    79 ( 10 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 1 20:00

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    End point title
    		 BP POD 1 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 1 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    79 ( 11 )
    79 ( 15 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 2 8:00

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    End point title
    		 BP POD 2 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 2 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    81 ( 21 )
    82 ( 10 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 2 20:00

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    End point title
    		 BP POD 2 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 2 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    81 ( 10 )
    80 ( 9 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 3 8:00

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    End point title
    		 BP POD 3 8:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 3 8:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    86 ( 14 )
    84 ( 10 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: BP POD 3 20:00

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    End point title
    		 BP POD 3 20:00
    End point description
    End point type
    Secondary
    End point timeframe
    blood pressure post operative day 3 20:00
    End point values
    		 sublingual sufentanil tablet system continuous morphine pump
    Number of subjects analysed
    31
    33
    Units: mmHg
        arithmetic mean (standard deviation)
    77 ( 10 )
    80 ( 12 )
    Statistical analysis title
    		 chi square
    Comparison groups
    sublingual sufentanil tablet system v continuous morphine pump
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    adverse events were assessed as from signing the ICF till post operative day 3 (end of study).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    subject group
    Reporting group description
    		 -

    Serious adverse events
    		 subject group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    hallucinations
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 subject group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 21 (95.24%)
    Cardiac disorders
    bradycardia
         subjects affected / exposed
    7 / 21 (33.33%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    hypotension
         subjects affected / exposed
    11 / 21 (52.38%)
         occurrences all number
    11
    Respiratory, thoracic and mediastinal disorders
    hypoventilation
         subjects affected / exposed
    2 / 21 (9.52%)
         occurrences all number
    2

    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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