Ignite Creation Date:
2024-05-06 @ 4:02 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02439034
Status:
UNKNOWN
Last Update Posted:
2016-07-28
First Post:
2015-04-30
Brief Title:
Paracetamol With or Without Ketoprofen in the Management of Pain for Patients Receiving Brachytherapy KETOCOL-1304
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
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:
None
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?:
None