Clinical Trial Results:
Jatkuvan haavapuudutuksen vaikutukset tavanomaiseen kipulääkitykseen lapsipotilailla sydänleikkauksen jälkeen
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Summary
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EudraCT number |
2008-008380-94 |
Trial protocol |
FI |
Global end of trial date |
07 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Feb 2020
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First version publication date |
01 Feb 2020
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Other versions |
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Summary report(s) |
Ropivacaine infusion for post sternotomy pain |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
Sternumhaavapuudutus
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Helsinki University Hospital
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Sponsor organisation address |
Stenbäckinkatu 11, Helsinki, Finland, 00029 HUS
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Public contact |
Department of Anesthesia and Intensive care, Helsinki University Hospital, +358 0504271648, arja.hiller@hus.fi
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Scientific contact |
Department of Anesthesia and Intensive care, Helsinki University Hospital, +358 0504271648, arja.hiller@hus.fi
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 May 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Oct 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Examine whether the continuous infusion of 0.2% ropivacaine decreases daily morphine consumption for 72 h in children who were undergoing ASd closure.
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Protection of trial subjects |
The study was approved by the institutional Ethics Committee
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Nov 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Finland: 49
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Worldwide total number of subjects |
49
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EEA total number of subjects |
49
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
49
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
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Pre-assignment
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Screening details |
A total of 49 children aged 1-9 years of ASA physical status II-IV who were undergoing ASD repair were enrolled | |||||||||
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Period 1
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Period 1 title |
Postoperative (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | |||||||||
Blinding implementation details |
Enrolled children were randomly assigned to a treatment by the sealed-envelope method. The study design was a series of blocks of fours, whereby a patient randomly received either a continuous wound infusion or ropivacaine or of saline. A nurse anesthetist who did not participate in the postoperative care of the enrolled children prepared all study medications according to the assigned group treatments.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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saline | |||||||||
Arm description |
continuos ropivacaine infusion was compare with same amount (ml) saline | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
ropivacain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Unknown use
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Dosage and administration details |
drugs were given to wound catheter parallel into the sternal wound above mediastinum
0.2% ropivacaine as a bolus 0.5 ml/kg and thereafter as continuos infuusion 0.3-0.4 mg/kg/h
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Investigational medicinal product name |
saline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Unknown use
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Dosage and administration details |
After skin closure, the surgeon injected a bolus of saline 0.5 ml/kg to wound catheter and thereafter continuous infusion of saline 1-7 ml/h depending on the weight of a child.
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Arm title
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ropivacaine | |||||||||
Arm description |
Continuous ropivacaine infusion was compared with same amount (ml) of saline | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
ropivacain
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Unknown use
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Dosage and administration details |
drugs were given to wound catheter parallel into the sternal wound above mediastinum
0.2% ropivacaine as a bolus 0.5 ml/kg and thereafter as continuos infuusion 0.3-0.4 mg/kg/h
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End points reporting groups
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Reporting group title |
saline
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Reporting group description |
continuos ropivacaine infusion was compare with same amount (ml) saline | ||
Reporting group title |
ropivacaine
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Reporting group description |
Continuous ropivacaine infusion was compared with same amount (ml) of saline | ||
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End point title |
change in morphine consumption between groups during 72 h | |||||||||||||||
End point description |
Morphine consumption mg/kg Control Ropivacaine
0-24 h 0.63 (0.30) 0.68 (0.25)
24-48 h 0.16 (0.10) 0.20 (0.18)
48-72 h 0.06 (0.07) 0.07 (0.12)
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End point type |
Primary
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End point timeframe |
72 h
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Statistical analysis title |
Statistical analysis | |||||||||||||||
Statistical analysis description |
Comparisons between the groups were performed using the Student`s t-test to compare means, the Mann-Whitney U-test to compare distributions nonparametrically, and Fisher´s exact test when appropriate.Normality of the distribution was assessed by Shapiro-Wilk W test, and depending on the results, either parametric or nonparametric analysis was performed. Data on demographics, surgery, anesthetics and doses of drug administered were analyzed using Student´´s t-test.
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Comparison groups |
saline v ropivacaine
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Number of subjects included in analysis |
49
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Analysis specification |
Pre-specified
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Analysis type |
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P-value |
< 0.5 [1] | |||||||||||||||
Method |
Fisher exact | |||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||
Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
0.05 | |||||||||||||||
upper limit |
0.05 | |||||||||||||||
Variability estimate |
Standard deviation
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| Notes [1] - A P-value <0.05 were considered significant. |
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Adverse events information
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Timeframe for reporting adverse events |
During 24 hrs hourly, 24-72 h every fourth hour
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Adverse event reporting additional description |
Daily questionnaire for ward nurses
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Assessment type |
Systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
ropivacaine
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Reporting group description |
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Reporting group title |
control
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
