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

Uterine Cervical Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Upper Aerodigestive Tract Neoplasms
• Uterine Cervical Cancer
• Uterine Cervical Neoplasms

• NCT number: NCT02439034
• Study type: Interventional
• Source: Centre Oscar Lambret
• Contact: Danièle LEFEBVRE-KUNTZ, MD
• Phone: +33 3 20 29 59 89
• Email: d-lefebvre@o-lambret.fr
• Status: Recruiting
• Phase: Phase 2
• Start date: February 2015
• Completion date: March 2018