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

Postoperative Pain Clinical Trial

— KEMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01146145
• Other study ID #: P020401
• Status: Completed
• Phase: N/A
• First received: June 16, 2010
• Last updated: June 16, 2010
• Start date: May 2003
• Est. completion date: January 2009

Study information

• Verified date: June 2010
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine
intravenous morphine titration combined to ketamine

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 h	No