Clinical Trial Results:
Comparison of pain and comfort in patients following cardiac surgery: opioid-morphine managed vs multimodal pain-management.
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Summary
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EudraCT number |
2019-000515-84 |
Trial protocol |
BE |
Global end of trial date |
03 Dec 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Aug 2024
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First version publication date |
02 Aug 2024
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Other versions |
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Summary report(s) |
Final Study Report |
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 |
AGO/2019/001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04987372 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UZ Gent - HIRUZ
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Sponsor organisation address |
C. Heymanslaan 10, Gent, Belgium, 9000
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Public contact |
HIRUZ CTU, Ghent University Hospital, 32 093320530, hiruz.ctu@uzgent.be
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Scientific contact |
HIRUZ CTU, Ghent University Hospital, 093320530 093320530, hiruz.ctu@uzgent.be
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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 |
09 Dec 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
03 Dec 2021
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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 |
To compare "Fentanyl-Tramadol-Paracetamol-Oxycodon" regimen to a multimodal painmanagement "pregabalin-minimal fentanyl-ketamine-lidocain-dexmedetomidine-paracetamol" to determin which therapy provides the most comfort, the fastest extubation time, the least pain and the least delirium.
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Protection of trial subjects |
The risks of the multimodal therapy can be estimated low, as the dosing regimen of the products is low. This low dosing is because of synergistic analgesic actions.
Intensive care unit (ICU) equipment includes patient monitoring, respiratory and cardiac support, pain management , emergency resuscitation devices, and other life support equipment designed to care for patients who are seriously injured, have a critical or life-threatening illness, or have undergone a major surgical procedure, thereby requiring 24-hour care and monitoring.
Patient monitoring equipment following cardiac surgery includes the following:
• Acute care physiologic monitoring system—comprehensive patient monitoring systems that can be configured to continuously measure and display a number of parameters via electrodes and sensors that are connected to the patient. These may include the electrical activity of the heart via an EKG, respiration rate (breathing), blood pressure, body temperature, cardiac output, and amount of oxygen and carbon dioxide in the blood. Each patient bed in an ICU has a physiologic monitor that measure these body activities.
• Pulse oximeter—monitors the arterial hemoglobin oxygen saturation (oxygen level) of the patient's blood with a sensor clipped over the finger or toe.
• Apnea monitor—continuously monitors breathing via electrodes or sensors placed on the patient. An apnea monitor detects cessation of breathing in infants and adults at risk of respiratory failure, displays respiration parameters, and triggers an alarm if a certain amount of time passes without a patient's breath being detected. Apnea monitoring may be a capability included in a physiologic monitor.
• The process of analysis and monitoring of arterial blood gas is an essential part of diagnosing and managing the oxygenation status and acid–base balance of patients during and following cardiac surgery in the operation room and in the Intensive Care Unit.
• Pain and agitation scales are standar
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Jun 2019
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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 |
Belgium: 96
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Worldwide total number of subjects |
96
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EEA total number of subjects |
96
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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) |
0
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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 |
96
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85 years and over |
0
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Recruitment
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Recruitment details |
See attachment Final Study Report | |||||||||
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Pre-assignment
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Screening details |
See attachment Final Study Report | |||||||||
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Period 1
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Period 1 title |
Overal Trial (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, Carer, Assessor | |||||||||
Blinding implementation details |
See attachment Final Study Report
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Classic | |||||||||
Arm description |
See attachment Final Study Report | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Multimodal | |||||||||
Arm description |
See attachment Final Study Report | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Pregabiline
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Infusion
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Dosage and administration details |
See attachment Final Study Report
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End points reporting groups
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Reporting group title |
Classic
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Reporting group description |
See attachment Final Study Report | ||
Reporting group title |
Multimodal
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Reporting group description |
See attachment Final Study Report | ||
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End point title |
Primary [1] | ||||||||||||
End point description |
See attachment Final Study Report
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End point type |
Primary
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End point timeframe |
During the study
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: See attachment Final Study Report |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Secondary | ||||||||||||
End point description |
See attachment Final Study Report
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End point type |
Secondary
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End point timeframe |
During the study
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
During the study
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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 |
0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| 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: See attachment Final Study Report |
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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 | |||
