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History of Changes for Study: NCT00329394
Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
Latest version (submitted October 7, 2008) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 23, 2006 None (earliest Version on record)
2 June 15, 2006 Study Status, Eligibility, Outcome Measures, Conditions and Study Description
3 June 22, 2006 Contacts/Locations and Study Status
4 November 13, 2007 Study Status, Eligibility, Arms and Interventions and Study Design
5 November 30, 2007 Study Status
6 October 7, 2008 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Study Design and Sponsor/Collaborators
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Study NCT00329394
Submitted Date:  May 23, 2006 (v1)

Open or close this module Study Identification
Unique Protocol ID: CHU63-008
Brief Title: Systemic Ketamine for the Improvement of Post-Operative Analgesia at the Alcohol-Dependent Patient
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.
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2006
Overall Status: Recruiting
Study Start: April 2006
Primary Completion:
Study Completion: April 2007
First Submitted: May 23, 2006
First Submitted that
Met QC Criteria:
May 23, 2006
First Posted: May 24, 2006 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 23, 2006
Last Update Posted: May 24, 2006 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Clermont-Ferrand
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief 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 alcoolo-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.
Open or close this module Conditions
Conditions: Alcoholic Patient
Carcinological Surgery ORL
Keywords: Ketamine
Analgesia
Alcoolo-dependent
carcinological surgery
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 56
Open or close this module Arms and Interventions
Intervention Details:
Drug: ketamine
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Morphine consumption at 48 hours
Secondary Outcome Measures:
1. pain
2. the ground (dependence with alcohol)
3. the first request analgesic
4. the tolerance and the signs psychic (syndrom of weaning...)
5. and the satisfaction of the patient
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • patient alcoolo-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
Open or close this module Contacts/Locations
Central Contact Person: Nicolas RASCOL, Dr
Telephone: (33)04 73 750 750
Study Officials: Nicolas RASCOL, Dr
Principal Investigator
University Hospital, Clermont-Ferrand
Locations: France
Chu de Clermont-Ferrand
[Recruiting]
Clermont-ferrand, France, 63000
Contact:Contact: Nicolas RASCOL, Doctor (33) 04 73 750 750
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: Elia N, Tramèr MR. Ketamine and postoperative pain--a quantitative systematic review of randomised trials. Pain. 2005 Jan;113(1-2):61-70. Review. PubMed 15621365
Petrakis 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. PubMed 15465973
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