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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ketamine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative, pain, analgesia, morphine, titration, ketamine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Louis Mourier

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment

placebo

Arm Description

intravenous morphine titration combined to ketamine

morphine titration alone

Outcomes

Primary Outcome Measures

analgesic efficacy
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

Secondary Outcome Measures

Full Information

First Posted
June 16, 2010
Last Updated
June 16, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01146145
Brief Title
Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Acronym
KEMO
Official Title
Efficacity, Safety and Cost of Intravenous Morphine Titration Alone or Combined to Ketamine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative, pain, analgesia, morphine, titration, ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
intravenous morphine titration combined to ketamine
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
morphine titration alone
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
two groups of patients recevieving, in the postanesthesia care unit either, intravenous morphine titration alone, or intravenous morphine titration combined to ketamine
Intervention Description
intravenous morphine titration combined to ketamine
Primary Outcome Measure Information:
Title
analgesic efficacy
Description
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
Time Frame
24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hawa Keita
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France

12. IPD Sharing Statement

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

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