Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

NCT01675986 | Completed Phase 2

• 1 other identifier: GABAPAC
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeling Anxious

Outcome Measures

Primary Outcomes (1)

• Efficacy treatment

  anxiety score VAS: 0 to 100

Secondary Outcomes (1)

• Efficacy of pregabaldin

Study Arms (3)

Pregabaline

EXPERIMENTAL

Groups PREGABALINE : 150 mg de LYRICA®

Drug: Pregabalin

Hydroxyzine

EXPERIMENTAL

Groups HYDROXYZINE : 75 mg d'ATARAX®

Drug: hydroxyzine

Lactose

PLACEBO COMPARATOR

Groups placebo : 4 g de lactose

Drug: Lactose

Interventions

hydroxyzine DRUG

75 mg

Hydroxyzine

Pregabalin DRUG

150 mg

Pregabaline

Lactose DRUG

4 g

Lactose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU de POITIERS

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Hydroxyzine; Pregabalin; Lactose

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Bertrand DEBAENE, MD

  Poitiers University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: August 30, 2012
• Primary Completion: November 1, 2014
• Last Updated: October 11, 2016

Record last verified: 2016-10

Locations

FR (1)