Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
238
Countries
1
Sites
4
Postoperative pain after cardiac surgery
Show that the use of NSAIDs reduces pain 24 hours after cardiac surgery
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 2 Dec 2024 → ongoing
- Decision date (initial)
- 2024-03-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- DGOS (PHRCIR 2021) and CHU Amiens-Picardie
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Show that the use of NSAIDs reduces pain 24 hours after cardiac surgery
Secondary objectives 8
- Postoperative pain during physiotherapy within 48 hours after cardiac surgery.
- Evolution of pain during the first 7 days after surgery
- Total cumulative opioid consumption during the 48 hours following surgery
- Compare the incidence of nausea and vomiting in the 48 hours following surgery
- Compare the incidence of postoperative pulmonary complications in the 28 days following surgery
- Compare the incidence of chronic postoperative pain 3 months after surgery
- - Compare the incidence of neuropathic pain at 48 hours and 3 months after surgery
- Compare the change in quality of life before and 3 months after surgery
Conditions and MedDRA coding
Postoperative pain after cardiac surgery
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Ketoprofen versus placebo in the management of postoperative pain after cardiac surgery Standard arm:
Standard analgesic protocol after surgery for 48 hours, paracetamol 1000 mg every 6 hours, Tramadol 50 mg every 6 hours, Nefopam 20 mg every 8 hours + placebo 100 mg intravenously every 8 hours for the 48 hours following surgery.
Experimental arm:
Standard analgesic protocol after surgery for 48 hours + Ketoprofen 100 mg intravenously every 8 hours for 48 hours following surgery.
|
Randomised Controlled | Double | [{"id":71602,"code":1,"name":"Subject"},{"id":71604,"code":2,"name":"Investigator"},{"id":71603,"code":4,"name":"Analyst"},{"id":71601,"code":3,"name":"Monitor"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patient aged 18 or older admitted for elective cardiac surgery under extracorporeal circulation
- Signed informed consent
Exclusion criteria 12
- Thoracotomy approach, 2 Minimally invasive approach
- Chronic use of NSAIDs before the operation
- Opioid dependence or chronic opioid medication
- Contraindications to the use of NSAIDs
- Emergency surgery
- Acute infectious endocarditis
- AIDS with a CD4 count <200/mm3
- Autoimmune disorder
- Advanced chronic kidney disease (CKD 4 or 5)
- Renal replacement therapy within the last 90 days
- Depression with long-term treatment
- History of gastrointestinal ulcer
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10
Secondary endpoints 7
- During chest physiotherapy, postoperative pain will be assessed as for the primary endpoint using the NRS
- Postoperative pain every day from the 1st to the 7th day between 8 a.m. and 12 p.m. as for the primary endpoint using the EN and the pain trajectory will be assessed taking into account the NRS between day 3 and day 7
- Nausea will be recorded according to a verbal scale (none, moderate, severe)
- postoperative pulmonary complications will be looked for in the first 7 days after surgery according to the European consensus definitions
- Chronic pain will be assessed at 48 hours and at 3 months by completing a concise pain questionnaire using the DN4 scale
- Neuropathic pain will be assessed at 48 hours
- Quality of life at 3 months will be assessed by the quality of life scale of the EQ-5D-5L questionnaire compared to the assessment the day before surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB08374MIG · Substance
- Active substance
- Ketoprofen
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 8000 millilitre(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09183MIG · Substance
- Active substance
- Nefopam
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11210MIG · Substance
- Active substance
- Tramadol
- Pharmaceutical form
- INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Coordinating investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Coordinating investigator
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 238 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Lille
Anesthésie et Réanimation, Boulevard Du Professeur Jules Leclercq, 59000, Lille
Centre Hospitalier Universitaire Amiens Picardie
Anesthésie et Réanimation, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHU De Rouen
réanimation en chirurgie cardiaque, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Centre Hospitalier Universitaire De Caen Normandie
Anesthésiologie et médecine de soins intensifs, Avenue De La Cote De Nacre, 14000, Caen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2024-12-02 | 2024-12-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | Procedures recrutement 26102023 | 1.1 |
| Subject information and informed consent form (for publication) | NIFC 26102023 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-28 | France | Acceptable 2024-03-26
|
2024-03-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-19 | France | Acceptable | 2025-07-16 |