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

NCT ID: NCT01146145

Last Updated: 2010-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-01-31

Brief Summary

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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

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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

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment

intravenous morphine titration combined to ketamine

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

intravenous morphine titration combined to ketamine

placebo

morphine titration alone

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

intravenous morphine titration combined to ketamine

Interventions

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Ketamine

intravenous morphine titration combined to ketamine

Intervention Type DRUG

Other Intervention Names

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two groups of patients recevieving in the postanesthesia care unit either intravenous morphine titration alone or intravenous morphine titration combined to ketamine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpemnt

Principal Investigators

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Hawa Keita

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hopital Louis Mourier

Colombes, , France

Site Status

Countries

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France

Other Identifiers

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P020401

Identifier Type: -

Identifier Source: org_study_id

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