Clinical trial NCT02439034: Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
Official title: Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Uterine Cervical Cancer
Upper Aerodigestive Tract Neoplasms
Keywords: pain management
brachytherapy
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Santelys Association
First posted: 2015-05-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: * 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

Eligibility 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

Primary outcomes:
measure: Level of immediate post-operative pain
timeFrame: Day 1
Secondary outcomes:
measure: Level of pain linked to the operative procedure during brachytherapy and at home
timeFrame: Day 1 (8, 12 hours), Days 3, 15 and 30
measure: Tolerance of the analgesic treatment
timeFrame: 30 days
measure: Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire
timeFrame: inclusion, Days 3 and 30
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Danièle LEFEBVRE-KUNTZ, MD
role: STUDY_DIRECTOR
affiliation: Centre Oscar Lambret
name: Nathalie LEROUX, MD
role: STUDY_DIRECTOR
References: