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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Unknown status

CT.gov ID

NCT02439034

Collaborator

Santelys Association (Other)

120

Enrollment

Location

Arms

36.9

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Cancer Upper Aerodigestive Tract Neoplasms	Drug: Paracetamol Drug: Ketoprofen	Phase 2

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:

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A Paracetamol	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
Experimental: Arm B Paracetamol + Ketoprofen	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

Intervention/Treatment

Active Comparator: Arm A

Paracetamol

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

Experimental: Arm B

Paracetamol + Ketoprofen

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

Outcome Measures

Primary Outcome Measures

Level of immediate post-operative pain [Day 1]
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.

Secondary Outcome Measures

Level of pain linked to the operative procedure during brachytherapy and at home [Day 1 (8, 12 hours), Days 3, 15 and 30]
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.
Tolerance of the analgesic treatment [30 days]
assessment based on NCI-CTCAE v4.0
Assessment of anxiety before, during and after brachytherapy by completing the HADS questionnaire [inclusion, Days 3 and 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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