Non-steroidal Anti-inflammatory Drugs in Pleurodesis

PHASE2RecruitingINTERVENTIONAL
Enrollment

358

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
Non-steroidal Anti-inflammatory DrugsPleurodesisPneumothoraxPain Management
Interventions
PROCEDURE

pleurodesis procedures

All pleurodesis procedures will be conducted with a general anesthesia. The choice of hypnotic, analgesic and neuromuscular drugs will be at the discretion of the physician. Selective orotracheal intubation will be done for all patients with a double lumen tube or a blocker according to centers habits. Regional anesthesia (serratus block, paravertebral block and erector spinae block) will be allowed and chosen at the discretion of the physician. Multimodal pain management will be allowed with the use dexamethasone, ketamine and antinociceptive drugs (nefopam, tramadol, paracetamol at the discretion of the physician. After the surgical procedure, the pleural production of liquid or air will be monitored with a chest tube connected to pleural drainage device according to centers habits. Pain will be monitored with during the hospital stay every 12 h using the pain rate scale graded from 0 to 10. Neuropathic pain will be screened at 48h, 1 months, 6 months and 1 year after the inclusion

DRUG

KETOPROFEN(RP19583)

one intravenous dose of ketoprofen 100 mg followed by 5 doses every 12 h of ketoprofen LP 100 mg (a total regimen of 6 doses of ketoprofen every 12 h for 72h)

DRUG

Placebo

placebo of ketoprofen with the schema of administration consisting in the administration of one intravenous dose of 100 ml of NaCl 0.9% following 6 oral intakes of a placebo pill every 12h (a total regimen of 6 doses of placebo of NSAID every 12 h for 72h)

Trial Locations (1)

80054

RECRUITING

Centre Hospitalier Universitaire d'Amiens, Amiens

All Listed Sponsors
collaborator

Centre Hospitalier VALENCIENNES

OTHER

collaborator

Clinique Victor Pauchet

OTHER

collaborator

University Hospital, Rouen

OTHER

lead

Centre Hospitalier Universitaire, Amiens

OTHER