Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484484
Status:
COMPLETED
Last Update Posted:
2011-05-04
First Post:
2007-06-08
Brief Title:
Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
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:
KETADOL
Brief Summary:
Long-term opioid therapy is commonly administered for the management of severe cancer pain Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur Ketamine an N-methyl-D-aspartate NMDA receptor antagonist has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain
Detailed Description:
Main objective
To show that low analgesic doses of ketamine associated with opioids better relieve refractory cancer pain than opioids without ketamine
Secondary objectives
Determine whether ketamine use allows to reduce opioid consumption
Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo
100 patients are expected 50 will be treated with opioids and ketamine 50 will be treated with opioids and a placebo
Treatment will be administered for 4 days Patients will be followed-up for 5 days
Success is defined by a decrease of the daily pain score of 50 after 4 days The expected rate of success in the placebo group is 10 whereas the expected rate of success in the ketamine group is 35
Primary outcome pain score on a 11-point numerical scale will be evaluated everyday as well as secondary outcomes patient and clinician global impression of change opioid consumption adverse reactions patient satisfaction on pain relief sleep interference score
Vital parameters cardiac frequency respiratory frequency and arterial blood pressure will be checked everyday many times a day every hour for the four hours after the beginning of the treatment and then every four hours every hour for the two hours following a dose shift
To show that low analgesic doses of ketamine associated with opioids better relieve refractory cancer pain than opioids without ketamine
Secondary objectives
Determine whether ketamine use allows to reduce opioid consumption
Evaluate the adverse effects of opioids-ketamine association versus opioids-placebo
100 patients are expected 50 will be treated with opioids and ketamine 50 will be treated with opioids and a placebo
Treatment will be administered for 4 days Patients will be followed-up for 5 days
Success is defined by a decrease of the daily pain score of 50 after 4 days The expected rate of success in the placebo group is 10 whereas the expected rate of success in the ketamine group is 35
Primary outcome pain score on a 11-point numerical scale will be evaluated everyday as well as secondary outcomes patient and clinician global impression of change opioid consumption adverse reactions patient satisfaction on pain relief sleep interference score
Vital parameters cardiac frequency respiratory frequency and arterial blood pressure will be checked everyday many times a day every hour for the four hours after the beginning of the treatment and then every four hours every hour for the two hours following a dose shift
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