Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:07 AM
Study NCT ID:
NCT02439034
Status:
UNKNOWN
Last Update Posted:
2016-07-28
First Post:
2015-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy (KETOCOL-1304)
Sponsor:
Centre Oscar Lambret
Organization:
Study Overview
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:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KETOCOL-1304
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: