NCT01146145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
Last Updated

June 17, 2010

Status Verified

June 1, 2010

Enrollment Period

5.7 years

First QC Date

June 16, 2010

Last Update Submit

June 16, 2010

Conditions

Postoperative Pain

Keywords

postoperativepainanalgesiamorphinetitrationketamine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

treatment

EXPERIMENTAL

intravenous morphine titration combined to ketamine

Drug: Ketamine

placebo

PLACEBO COMPARATOR

morphine titration alone

Drug: Ketamine

Interventions

KetamineDRUG

intravenous morphine titration combined to ketamine

Also known as: two groups of patients recevieving, in the postanesthesia care unit either, intravenous morphine titration alone, or intravenous morphine titration combined to ketamine
placebotreatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age \< 18 yrs
  • Locoregional anesthesia or analgesia
  • Allergia to morphine or ketamine
  • Morphine or ketamine contraindication
  • Pregnancy or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Mourier

Colombes, 92700, France

Location

MeSH Terms

Conditions

Pain, PostoperativePainAgnosia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Hawa Keita

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

May 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 17, 2010

Record last verified: 2010-06

Locations

FR(1)