| May 23, 2006 |
| October 7, 2008 |
| April 2006 |
| September 2008 (final data collection date for primary outcome measure) |
| Morphine consumption at 48 hours [ Time Frame: at 48 hours ] [ Designated as safety issue: Yes ] |
| Morphine consumption at 48 hours |
| Complete list of historical versions of study NCT00329394 on ClinicalTrials.gov Archive Site |
- pain [ Time Frame: pain ] [ Designated as safety issue: Yes ]
- the ground (dependence with alcohol) [ Time Frame: dependence with alcohol ] [ Designated as safety issue: Yes ]
- the first request analgesic [ Time Frame: the first request analgesic ] [ Designated as safety issue: Yes ]
- the tolerance and the signs psychic (syndrome of weaning...) [ Time Frame: the tolerance and the signs psychic ] [ Designated as safety issue: Yes ]
- and the satisfaction of the patient [ Time Frame: the satisfaction of the patient ] [ Designated as safety issue: Yes ]
|
- pain
- the ground (dependence with alcohol)
- the first request analgesic
- the tolerance and the signs psychic (syndrom of weaning...)
- and the satisfaction of the patient
|
| |
| Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient |
| Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient. |
The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient. |
The principal objective is to evaluate the analgesic effectiveness of the systemic ketamine on the control of the pain (average consumption of morphine at 48 hours) at the alcool-dependent patient, in carcinological surgery ORL. The effect coanalgesic is found for low dose of ketamine and action anti NMDA seems to have a stabilizing effect on this particular type of patient. This imbalance of the receivers, with a greater number of r-NMDA among these patients would involve it a better analgesic effectiveness and less effects dysphoric, to see an improvement on the syndrome of weaning. The secondary objectives evaluate the pain, the ground (dependence with alcohol), the first request analgesic, the tolerance and the signs psychic (syndrome of weaning...) and the satisfaction of the patient. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
- Alcoholic Patient
- Carcinological Surgery ORL
|
| Drug: ketamine |
| |
|
|
| |
| Suspended |
| 56 |
| September 2008 |
| September 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3
Exclusion Criteria:
- refusal of the patient
- counter-indications with the treatments,
- urgency
- the specific clinical context (final neoplasy, reanimation)
- the treatments for chronic pain containing morphinic
|
| Both |
| 18 Years to 70 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00329394 |
| Dr Nicolas RASCOL, CHU Clermont-Ferrand |
| CHU63-008 |
| University Hospital, Clermont-Ferrand |
|
| Principal Investigator: |
Nicolas Rascol, Dr |
University Hospital, Clermont-Ferrand |
|
|
| University Hospital, Clermont-Ferrand |
| October 2008 |