NCT02439034

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

Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Paracetamol	Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2015-05-08
• Last updated: 2026-03-16

Locations

1 site across 1 country: France