The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.
* 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: 1. paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain : 2. 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
Ketoprofen\* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.
Centre Oscar Lambret
Lille, France
RECRUITINGLevel of immediate post-operative pain
Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is \< 4, 4 hours after the surgical operation.
Time frame: Day 1
Level of pain linked to the operative procedure during brachytherapy and at home
Assessment of the pain level at 8, 12 hours after the operative procedure, then twice a day during hospital stay or at home until the absence of pain during 2 consecutive days. This level will also be measured at days 3, 15 and 30 at hospital or during a phone interview (Days 3 and 15) and by the algologist of the investigation center on Day 30.
Time frame: Day 1 (8, 12 hours), Days 3, 15 and 30
Tolerance of the analgesic treatment
assessment based on NCI-CTCAE v4.0
Time frame: 30 days
Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire
Time frame: inclusion, Days 3 and 30
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