Acute Postoperative PainPhase 3KETOPAINNCT06381063
Non-steroidal Anti-inflammatory in Cardiac Surgery
A Phase 3 study testing pain management and ketoprofen in people with Acute Postoperative Pain and Non-steroidal Anti-inflammatory Drugs, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery
- What is being tested?
- pain management and ketoprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
- under cardiopulmonary bypass
- Affiliation to the French national healthcare system
- Written consent obtained
Who cannot join
- age<18
- weight<50 kg
- chronic use of NSAID
- mini-invasive surgery
- NSAID contraindication
- NSAID allergy
Show all 19Show fewer
- Nefopam contraindication
- Paracetamol contraindication
- Tramadol contraindication
- Urgent surgery
- Endocarditis
- Immunosuppressive drug
- HIV infection with CD4<200 mm3
- Organ transplantation
- Stage 4 or 5 chronic kidney disease
- Gastro duodenal ulcer
- Pregnancy
- Depression
- Auto immune disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Osama ABOU ARAB, abouarab.osama@chu-amiens.fr
Emmanuel BESNIER, MD
About this study
Official title: Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.
- Conditions
- Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery, Pain Intensity, Multimodal Pain Management
- Being tested
- pain management, ketoprofen, PLacebo
- Keywords
- Acute Postoperative Pain, non-steroidal anti-inflammatory drugs, cardiac surgery, pain intensity, multimodal pain management
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain managementDrug
- Pain management in both arms Intraoperative time: intravenous ketamine 0.5 mg kg-1, intravenous dexamethasone 8 mg Postoperative time: paracetamol 1 g every 6 hours a day, nefopam 20 every 8 hours a day, patient control analgesia with morphine or oxycontin
ketoprofenDrug
Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration
PLaceboDrug
Placebo twice a day, during 48 h after surgery, intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen | Experimental | Ketoprofen 100 mg twice a day, during 48 after surgery, intravenous administration Receives: Drug: pain management; Drug: ketoprofen |
| Placebo | Placebo comparator | Placebo twice a day, during 48 h after surgery, intravenous administration Receives: Drug: pain management; Drug: PLacebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery
Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
Measured: at 24 hours
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
Pain intensity will be assessed at rest at 24 hours from the end surgery using the numerous rating scale (NRS) graded from 1 (no pain) to 10 (high pain intensity)
Measured: at 24 hours
Secondary outcomes (3)
Change in pain trajectory during the first 7 days after cardiac surgery
Pain trajectory will be assessed every day using NRS and trajectory will be defined as following
Measured: 7 days
Change in cumulative opioid within 48 hours after surgery
Total dose of oxynorm or morphine will be recorded from the end of surgery to 48 h after and expressed in milligram
Measured: 48 hours
Change in pulmonary postoperative complications within 7 days after surgery
Postoperative pulmonary complications will be defined by the occurrence of at least one item among following: atelectasis, pneumonia, acute respiratory distress syndrome, acute respiratory failure, bronchospasm
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start27 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Lille, University Hospital, Caen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381063
- Sponsor's protocol ID
- PI2023_843_0152
- Acronym
- KETOPAIN
- Status last verified
- Jul 2025
- First submitted
- 5 Apr 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huette P, Moussa M, Diouf M, Lefebvre T, Bayart G, Guilbart M, Viart C, Haye G, Bar S, Caus T, Soriot-Thomas S, Boddaert S, Alshatri HY, Tarpin P, Fumery O, Beyls C, Dupont H, Mahjoub Y, Besnier E, Abou-Arab O. Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study). Trials. 2024 Sep 16;25(1):613. doi: 10.1186/s13063-024-08326-z.
PubMed 39285437
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-steroidal Anti-inflammatory Drugs in Pain Management After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06381063
- Acronym / sponsor ID
- KETOPAIN / PI2023_843_0152
- Conditions
- Acute Postoperative Pain, Non-steroidal Anti-inflammatory Drugs, Cardiac Surgery, Pain Intensity, Multimodal Pain Management
- Keywords
- Acute Postoperative Pain, non-steroidal anti-inflammatory drugs, cardiac surgery, pain intensity, multimodal pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- University Hospital, Rouen, University Hospital, Lille, University Hospital, Caen
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-steroidal anti-inflammatory drugs (NSAID) are part the multimodal strategy in pain management after surgery. However, major concerns are raised in cardiac surgery given the potential side effects of NSAID with more bleeding and acute kidney injury. The investigators hypothesized that NSAID are safe in the early postoperative course after cardiac surgery with respect to contraindication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen | Experimental | Drug: pain management, Drug: ketoprofenKetoprofen 100 mg twice a day, during 48 after surgery, intravenous administration |
| Placebo | Placebo comparator | Drug: pain management, Drug: PLaceboPlacebo twice a day, during 48 h after surgery, intravenous administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- scheduled for cardiac surgery (aortic valve replacement, coronary artery bypass graft, mitral valve repair or replacement, intracardiac tumor, aortic root repair)
- under cardiopulmonary bypass
- Affiliation to the French national healthcare system
- Written consent obtained
Key exclusion criteria (19 listed)
- age<18
- weight<50 kg
- chronic use of NSAID
- mini-invasive surgery
- NSAID contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain managemento Pain management in both arms Intraoperative time: intravenous ketamine 0.5 mg kg-1, intravenous dexamethasone 8 mg Postoperative time: paracetamol 1 g every 6 hours a day, nefopam 20 every 8 hours a day, patient control analgesia with morphine or oxycontin | Drug | Ketoprofen, Placebo |
| ketoprofenKetoprofen 100 mg twice a day, during 48 after surgery, intravenous administration | Drug | Ketoprofen |
| PLaceboPlacebo twice a day, during 48 h after surgery, intravenous administration | Drug | Placebo |
Primary outcome
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery
Time frame: at 24 hours
Pain intensity will be assessed using the NRS at 24 hours from the end of surgery during chest physiotherapy
NSAIDs reduce postoperative at rest at 24 hours from the end of surgery
Time frame: at 24 hours
Pain intensity will be assessed at rest at 24 hours from the end surgery using the numerous rating scale (NRS) graded from 1 (no pain) to 10 (high pain intensity)
3 secondary outcomes
Change in pain trajectory during the first 7 days after cardiac surgery
Time frame: 7 days
Change in cumulative opioid within 48 hours after surgery
Time frame: 48 hours
Change in pulmonary postoperative complications within 7 days after surgery
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 39285437Huette P, Moussa M, Diouf M, Lefebvre T, Bayart G, Guilbart M, Viart C, Haye G, Bar S, Caus T, Soriot-Thomas S, Boddaert S, Alshatri HY, Tarpin P, Fumery O, Beyls C, Dupont H, Mahjoub Y, Besnier E, Abou-Arab O. Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study). Trials. 2024 Sep 16;25(1):613. doi: 10.1186/s13063-024-08326-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pain management and ketoprofen in people with Acute Postoperative Pain and Non-steroidal Anti-inflammatory Drugs, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama ABOU ARAB, Pr (03 22 08 78 36, abouarab.osama@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in pain intensity during chest physiotherapy at 24 hours from the end of surgery (time frame: at 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.