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

NCT ID: NCT02439034

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-03-31

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

Conditions

Uterine Cervical Cancer; Upper Aerodigestive Tract Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Paracetamol

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

Arm B

Paracetamol + Ketoprofen

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

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

Ketoprofen

Intervention Type: DRUG

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

Interventions

Paracetamol

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

PARACETAMOL B BRAUN; PARACETAMOL CODEINE ARROW; BI PROFENID LP; PROFENID

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Santelys Association

OTHER

Sponsor Role: collaborator

Centre Oscar Lambret

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danièle LEFEBVRE-KUNTZ, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Nathalie LEROUX, MD

Role: STUDY_DIRECTOR

Centre Oscar Lambret

Locations

Centre Oscar Lambret

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Danièle LEFEBVRE-KUNTZ, MD

Role: CONTACT

d-lefebvre@o-lambret.fr

+33 3 20 29 59 89

Nathalie LEROUX-BROMBERG, MD

Role: CONTACT

n-leroux@o-lambret.fr

+33 3 20 29 59 89

Facility Contacts

Danièle Lefebvre-Kuntz, MD

Role: primary

d-lefebvre@o-lambret.fr

+33 3 20 29 59 89

Nathalie Leroux-Bromberg, MD

Role: backup

n-leroux@o-lambret.fr

+33 3 20 29 59 89

Other Identifiers

KETOCOL-1304

Identifier Type: -

Identifier Source: org_study_id