Alcoholic PatientPhase 3NCT00329394
Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
A Phase 3 study testing ketamine in people with Alcoholic Patient and Carcinological Surgery ORL, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcoholic Patient, Carcinological Surgery ORL
- What is being tested?
- ketamine
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2006to Sep 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3
Who cannot join
- refusal of the patient
- counter-indications with the treatments,
- urgency
- the specific clinical context (final neoplasy, reanimation)
- the treatments for chronic pain containing morphinic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Alcoholic Patient, Carcinological Surgery ORL
- Being tested
- ketamine
- Keywords
- Ketamine, Analgesia, Alcool-dependent, carcinological surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Evaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption at 48 hours
Measured: at 48 hours
Secondary outcomes (5)
pain
Measured: pain
the ground (dependence with alcohol)
Measured: dependence with alcohol
the first request analgesic
Measured: the first request analgesic
the tolerance and the signs psychic (syndrome of weaning...)
Measured: the tolerance and the signs psychic
and the satisfaction of the patient
Measured: the satisfaction of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2008 (estimated)
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcoholic PatientStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Nicolas Rascol, Dr, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329394
- Sponsor's protocol ID
- CHU63-008
- Status last verified
- Oct 2008
- First submitted
- 23 May 2006
- Last updated
- 8 Oct 2008
- Results posted
- No
Publications
Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
PubMed 15621365Petrakis IL, Limoncelli D, Gueorguieva R, Jatlow P, Boutros NN, Trevisan L, Gelernter J, Krystal JH. Altered NMDA glutamate receptor antagonist response in individuals with a family vulnerability to alcoholism. Am J Psychiatry. 2004 Oct;161(10):1776-82. doi: 10.1176/ajp.161.10.1776.
PubMed 15465973
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacity of the Systemic Ketamine for the Improvement of Post-Operative Analgesia After ORL Carcinological Surgery at the Alcohol-Dependent Patient.
- ClinicalTrials.gov ID
- NCT00329394
- Acronym / sponsor ID
- CHU63-008
- Conditions
- Alcoholic Patient, Carcinological Surgery ORL
- Keywords
- Ketamine, Analgesia, Alcool-dependent, carcinological surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Suspended
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Sep 2008 (estimated)
- Study completion
- Sep 2008 (estimated)
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient alcohol-dependent having to undergo a carcinological surgery ORL with tracheotomy or tracheostomy, ASA 1-3
Key exclusion criteria (5 listed)
- refusal of the patient
- counter-indications with the treatments,
- urgency
- the specific clinical context (final neoplasy, reanimation)
- the treatments for chronic pain containing morphinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketamineEvaluate the analgesic effectiveness of the systemic ketamine on the control of pain in the alcohol-dependent patient | Drug | – |
Primary outcome
Morphine consumption at 48 hours
Time frame: at 48 hours
5 secondary outcomes
pain
Time frame: pain
the ground (dependence with alcohol)
Time frame: dependence with alcohol
the first request analgesic
Time frame: the first request analgesic
the tolerance and the signs psychic (syndrome of weaning...)
Time frame: the tolerance and the signs psychic
and the satisfaction of the patient
Time frame: the satisfaction of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2008.
- Background: PubMed 15621365Elia N, Tramer MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. doi: 10.1016/j.pain.2004.09.036.
- Background: PubMed 15465973Petrakis IL, Limoncelli D, Gueorguieva R, Jatlow P, Boutros NN, Trevisan L, Gelernter J, Krystal JH. Altered NMDA glutamate receptor antagonist response in individuals with a family vulnerability to alcoholism. Am J Psychiatry. 2004 Oct;161(10):1776-82. doi: 10.1176/ajp.161.10.1776.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Rascol, Dr principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketamine in people with Alcoholic Patient and Carcinological Surgery ORL, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption at 48 hours (time frame: at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00329394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2008.