Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)

• Selection criteria validation
• Patient information and collection of a signed informed consent
• Randomization
• Completion of HADS questionnaire
• Day 1 = Begin of analgesic treatment / brachytherapy
• T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
• T0= end of the operative procedure under general anesthesia
• T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:

• paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
• paracetamol and morphine (Arms A and B)
• Day 2 to Day 30: At home or during hospital stay:

Pain assessment twice a day by the patient until absence of pain during 2 consecutive days

• Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
• Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire

In any case, pain assessment must be done until absence of pain during 2 consecutive days

Inclusion criteria

• Patient with a uterine cervical cancer or an upper aero-digestive tract cancer
• Age ≥ 18 years and ≤ 75 years
• Patient who are eligible for brachytherapy treatment associated with or without hospital stay
• With operative procedure under general anesthesia to set up the material needed for brachytherapy
• Performance status ≤ 2
• Creatinine Clearance ≥ 60 ml/min using Cockcroft equation
• No coagulation disorder or anticoagulation therapy at curative dose
• Registered with a social security system
• Patient having dated and signed an informed consent form before initiation of any study procedures

Exclusion criteria

• Respiratory pathology (SpO2< 70 %)
• Severe undernutrition
• Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs
• Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID
• Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage
• Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified)
• Liver insufficiency
• Severe renal insufficiency
• Severe heart failure
• Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors
• Intolerance or hypersensitivity to one of the treatments or excipients
• Inability to swallow
• Pregnant or breastfeeding woman
• Patient under tutorship or guardianship