Non-steroidal Anti-inflammatory Drugs in Pleurodesis (KETOTHORAX)

Centre Hospitalier Universitaire, Amiens

Status and phase: Enrolling; Phase 2

Conditions: Pneumothorax; Non-steroidal Anti-inflammatory Drugs; Pain Management; Pleurodesis

Treatments: Procedure: pleurodesis procedures; Drug: KETOPROFEN(RP19583); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06731647

PI2021_843_0175

Details and patient eligibility

About

Non-steroidal anti-inflammatory drugs (NSAIDs) are recommended in a multimodal pain management to reduce pain intensity and to spare opioid use. However, there is a controversy in its use in pleurodesis surgery as it could block the process of pleurodesis in surgical pneumothorax. In addition, NSAIDs could increase the risk of pneumothorax recurrence.

The investigators hypothesized that NSAIDs are safe during pleurodesis with a better pain management without increasing the risk of pneumothorax reccurence.

Enrollment: 358 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age≥18-year-old
• pneumothorax with an indication of pleurodesis
• with or without minimal lung resection
• via thoracotomy or thoracoscopy

Exclusion criteria

• Minor patient
• Pregnant, parturient or breast-feeding patient
• Severe polytrauma (associated with the presence of a Vittel criterion)
• Purulent pleurisy
• Hemopneumothorax
• Lactose hyper sensibility
• Contraindications to NSAID
• Contraindications to tramadol
• Contraindications to paracetamol
• Curative anticoagulation
• Patients under guardians or deprived of their liberty
• Patient refusal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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358 participants in 2 patient groups, including a placebo group

Interventional group

Experimental group

Description:

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)

Treatment:

Drug: KETOPROFEN(RP19583)

Procedure: pleurodesis procedures

Control group

Placebo Comparator group

Description:

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)

Treatment:

Drug: Placebo

Procedure: pleurodesis procedures