Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Poitiers University Hospital

ClinicalTrials.gov Identifier:

NCT01675986

First received: February 7, 2012

Last updated: October 10, 2016

Last verified: October 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2012

Last Updated Date

October 10, 2016

Start Date ^ICMJE

Not Provided

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy treatment

anxiety score VAS: 0 to 100

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01675986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of pregabaldin

anxiety score VAS:0 to 100

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Feeling Anxious

Intervention ^ICMJE

Drug: hydroxyzine
75 mg
Drug: Pregabalin
150 mg
Drug: Lactose
4 g

Study Arms

Experimental: Pregabaline
Groups PREGABALINE : 150 mg de LYRICA®

Intervention: Drug: Pregabalin
Experimental: Hydroxyzine
Groups HYDROXYZINE : 75 mg d'ATARAX®

Intervention: Drug: hydroxyzine
Placebo Comparator: Lactose
Groups placebo : 4 g de lactose

Intervention: Drug: Lactose

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

306

Completion Date

Not Provided

Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients aged from 18 to 75 years
Patient schedules for insertion of long-lasting intravenous device

Exclusion Criteria:

History of previous insertion of long-lasting intravenous device or central intravenous catheter
long term treatment of gabapentin or pregabalin
Hypersensitivity to pregabalin or any of the excipients
Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
Patient at risk of glaucoma e
Patient at risk for urinary retention
Patient severe respiratory failure
Patient at the general condition not too corrupted (ASA IV)
Renal failure with creatinin clearance < 30 ml / min
Patient not affiliated to Social Security
Pregnant or lactating
Patients in emergency situations
Inpatient without consent

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01675986

Other Study ID Numbers ^ICMJE

GABAPAC

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Poitiers University Hospital

Study Sponsor ^ICMJE

Poitiers University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bertrand DEBAENE, MD

Poitiers University Hospital

PRS Account

Poitiers University Hospital

Verification Date

October 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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