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Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine (KEMO)

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ClinicalTrials.gov Identifier: NCT01146145
Recruitment Status : Completed
First Posted : June 17, 2010
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 17, 2010
Last Update Posted Date June 17, 2010
Study Start Date  ICMJE May 2003
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2010)
analgesic efficacy [ Time Frame: 24 h ]
the analgesic efficacy, in two groups of patients recevieving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Official Title  ICMJE Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Brief Summary This is a randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine.
Detailed Description Randomised, controlled, double blinded study comparing in the postoperative setting the analgesic efficacy, the safety and the cost in two groups of patients receiving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE Drug: Ketamine
intravenous morphine titration combined to ketamine
Other Names:
  • two groups of patients recevieving
  • in the postanesthesia care unit either
  • intravenous morphine titration alone
  • or intravenous morphine titration combined to ketamine
Study Arms  ICMJE
  • Experimental: treatment
    intravenous morphine titration combined to ketamine
    Intervention: Drug: Ketamine
  • Placebo Comparator: placebo
    morphine titration alone
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2010)
160
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 yrs
  • scheduled surgery
  • General anesthesia
  • ASA I to III
  • Able to use a VAS
  • No psychological disorders, able to speak french

Exclusion Criteria:

  • Age < 18 yrs
  • Locoregional anesthesia or analgesia
  • Allergia to morphine or ketamine
  • Morphine or ketamine contraindication
  • Pregnancy or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146145
Other Study ID Numbers  ICMJE P020401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zakia IDIR, Department Clinical Research of Developpemnt
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hawa Keita Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP