Completed

Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

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What is being tested

Pregabalin

+ hydroxyzine

+ Lactose

Drug
Who is being recruted

Mental Disorders

+ Anxiety Disorders

From 18 to 75 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-ControlledPhase 2
Interventional
See protocol details

Summary

Principal SponsorPoitiers University Hospital
Last updated: October 11, 2016
Sourced from a government-validated database.Claim as a partner

The insertion of long-lasting intravenous device is done under local anesthesia. Currently, in the investigators hospital, no premedication is given to the patients. However, this procedure occurs in a particular emotional context related to the diagnosis of cancer or malign hemopathies. Therefore, administration of a sedative or anxiolytic drugs before the start of the procedure can be questionable. Hydroxyzine is the reference molecule for premedication because of its anxiolytic and anti-histaminic properties A new agent, pregabalin, shares also the same properties The main objective of this study was to compare the efficacy of pregabalin and hydroxyzine on the anxiety score as a premedication during the insertion of long-lasting intravenous device under local anesthesia.

NCT01675986
Principal SponsorPoitiers University Hospital
Last updated: October 11, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

306 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersAnxiety Disorders

Criteria

2 inclusion criteria required to participate
Patient schedules for insertion of long-lasting intravenous device
Patients aged from 18 to 75 years
13 exclusion criteria prevent from participating
History of previous insertion of long-lasting intravenous device or central intravenous catheter
Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine
Hypersensitivity to pregabalin or any of the excipients
Inpatient without consent
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Groups PREGABALINE : 150 mg de LYRICA®

Group II

Experimental
Groups HYDROXYZINE : 75 mg d'ATARAX®

Group III

Placebo
Groups placebo : 4 g de lactose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

CHU de POITIERS

Poitiers, FranceOpen CHU de POITIERS in Google Maps
CompletedOne Study Center