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

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: SANTELYS; Santelys Association
• Treatments: Acetaminophen; Codeine; 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