Clinical trial • Cardiology

Ketoprofen for Postoperative pain after cardiac surgery

Clinical trial of Ketoprofen for Postoperative pain after cardiac surgery.

Overview

Trial Therapeutic Area: Cardiology
Trial Disease: Postoperative pain after cardiac surgery
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 28-12-2023
First CTIS Authorization Date: 27-03-2024

Trial design

Randomised, 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.-controlled trial across 4 sites in France.

Randomised: Yes
Comparator: 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.
Target Sample Size: 238
Trial Duration For Participant: 90

Eligibility

Recruits 238 No vulnerable populations selected. Informed consent required: 'Signed informed consent' from adult participants (aged 18 or older)..

Vulnerable Population: No vulnerable populations selected. Informed consent required: 'Signed informed consent' from adult participants (aged 18 or older).

Inclusion criteria

{"criterion_text":"- Patient aged 18 or older admitted for elective cardiac surgery under extracorporeal circulation\n- Signed informed consent"}

Exclusion criteria

{"criterion_text":"- Thoracotomy approach, 2 Minimally invasive approach\n- Renal replacement therapy within the last 90 days\n- Depression with long-term treatment\n- History of gastrointestinal ulcer\n- Chronic use of NSAIDs before the operation\n- Opioid dependence or chronic opioid medication\n- Contraindications to the use of NSAIDs\n- Emergency surgery\n- Acute infectious endocarditis\n- AIDS with a CD4 count <200/mm3\n- Autoimmune disorder\n- Advanced chronic kidney disease (CKD 4 or 5)"}

Endpoints

Primary endpoints

{"endpoint_text":"- Postoperative pain at rest will be assessed at 24 hours using a numerical rating scale (NRS) graded from 0 to 10","definition_or_measurement_approach":"Assessment at 24 hours using a numerical rating scale (NRS) graded from 0 to 10"}

Secondary endpoints

{"endpoint_text":"- During chest physiotherapy, postoperative pain will be assessed as for the primary endpoint using the NRS","definition_or_measurement_approach":"Assessed using the NRS (numerical rating scale) as per primary endpoint during chest physiotherapy"}
{"endpoint_text":"- 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","definition_or_measurement_approach":"Daily assessments days 1–7 between 08:00 and 12:00 using NRS; pain trajectory assessed using NRS between day 3 and day 7"}
{"endpoint_text":"- Nausea will be recorded according to a verbal scale (none, moderate, severe)","definition_or_measurement_approach":"Recorded on a verbal scale with categories none, moderate, severe"}
{"endpoint_text":"- postoperative pulmonary complications will be looked for in the first 7 days after surgery according to the European consensus definitions","definition_or_measurement_approach":"Assessed in first 7 days post-surgery using European consensus definitions for postoperative pulmonary complications"}
{"endpoint_text":"- Chronic pain will be assessed at 48 hours and at 3 months by completing a concise pain questionnaire using the DN4 scale","definition_or_measurement_approach":"Assessed at 48 hours and at 3 months using a concise pain questionnaire with the DN4 scale"}
{"endpoint_text":"- Neuropathic pain will be assessed at 48 hours","definition_or_measurement_approach":"Assessed at 48 hours (method not further specified beyond DN4 use for chronic pain)"}
{"endpoint_text":"- 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","definition_or_measurement_approach":"Assessed at 3 months using the EQ-5D-5L quality of life questionnaire compared to pre-surgery assessment"}

Recruitment

Planned Sample Size: 238
Recruitment Window Months: 38
Consent Approach: Signed informed consent required from participants (adults aged 18 or older). Subject information and informed consent form document is listed for publication; specific languages or age-specific documents not specified.

Geography

Total Number Of Sites: 4
Total Number Of Participants: 238

France

Earliest CTIS Part Ii Submission Date: 17-01-2024
Latest Decision Or Authorization Date: 16-07-2025
Processing Time Days: 546
Number Of Sites: 4
Number Of Participants: 238

Sites

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: Anesthésie et Réanimation
Contact Person Name: Mohamed MOUSSA
Contact Person Email: mouhamed.moussa@chru-lille.fr

Site Name: Centre Hospitalier Universitaire Amiens Picardie
Department Name: Anesthésie et Réanimation
Contact Person Name: Osama ABOU ARAB
Contact Person Email: abouarab.osama@chu-amiens

Site Name: CHU De Rouen
Department Name: réanimation en chirurgie cardiaque
Contact Person Name: Emmanuel BESNIER
Contact Person Email: emmanuel.besnier@chu-rouen.fr

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: Anesthésiologie et médecine de soins intensifs
Contact Person Name: Richard DESCAMPS
Contact Person Email: descamps-r@chu-caen.fr

Sponsor

Primary sponsor

Full Name: Centre Hospitalier Universitaire Amiens Picardie
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: France

Investigational products

Investigational Product Name: KETOPROFEN
Active Substance: Ketoprofen
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INJECTION
Route: IV
Starting Dose: 100 mg intravenously every 8 hours for 48 hours
Dose Levels: 100 mg
Frequency: Every 8 hours
Maximum Dose: 200 mg (max daily dose amount in product record)

Investigational Product Name: SODIUM CHLORIDE
Active Substance: Sodium chloride
Modality: Small molecule
Routes Of Administration: IV INJECTION, IV INFUSION
Route: IV
Starting Dose: Placebo 100 mg intravenously every 8 hours for 48 hours (as per standard arm description)
Dose Levels: 100 mg (placebo equivalent)
Frequency: Every 8 hours
Maximum Dose: 200 mg (max daily dose amount in product record)

Investigational Product Name: PARACETAMOL
Active Substance: Paracetamol
Modality: Small molecule
Routes Of Administration: SOLUTION FOR INFUSION
Route: IV/infusion
Starting Dose: 1000 mg every 6 hours for 48 hours (standard analgesic protocol)
Dose Levels: 1000 mg
Frequency: Every 6 hours
Maximum Dose: 4000 mg (max daily dose amount in product record)

Investigational Product Name: TRAMADOL
Active Substance: Tramadol
Modality: Small molecule
Routes Of Administration: INJECTION
Route: IV/infusion
Starting Dose: 50 mg every 6 hours for 48 hours (standard analgesic protocol)
Dose Levels: 50 mg
Frequency: Every 6 hours
Maximum Dose: 200 mg (max daily dose amount in product record)

Investigational Product Name: NEFOPAM
Active Substance: Nefopam
Modality: Small molecule
Routes Of Administration: INFUSION
Route: IV/infusion
Starting Dose: 20 mg every 8 hours for 48 hours (standard analgesic protocol)
Dose Levels: 20 mg
Frequency: Every 8 hours
Maximum Dose: 60 mg (max daily dose amount in product record)

Combination Treatment: Yes

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