Trial | NCT02439034  Report issue

Title

Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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:

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
Study Started
Feb 28
2015
Primary Completion
Feb 28
2018
Anticipated
Study Completion
Mar 31
2018
Anticipated
Last Update
Jul 28
2016
Estimate

Drug Paracetamol

Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)

  • Other names: PARACETAMOL B BRAUN, PARACETAMOL CODEINE ARROW

Drug Ketoprofen

Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.

  • Other names: BI PROFENID LP, PROFENID

Arm A Active Comparator

Paracetamol

Arm B Experimental

Paracetamol + Ketoprofen

Criteria 

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
No Results Posted