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Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

This study has been completed.
Information provided by (Responsible Party):
Poitiers University Hospital Identifier:
First received: February 7, 2012
Last updated: October 10, 2016
Last verified: October 2016

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.

Condition Intervention Phase
Feeling Anxious Drug: hydroxyzine Drug: Pregabalin Drug: Lactose Phase 2

Study Type: Interventional

Resource links provided by NLM:

Further study details as provided by Poitiers University Hospital:

Primary Outcome Measures:
  • Efficacy treatment
    anxiety score VAS: 0 to 100

Secondary Outcome Measures:
  • Efficacy of pregabaldin
    anxiety score VAS:0 to 100

Enrollment: 306
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pregabaline
Groups PREGABALINE : 150 mg de LYRICA®
Drug: Pregabalin
150 mg
Experimental: Hydroxyzine
Groups HYDROXYZINE : 75 mg d'ATARAX®
Drug: hydroxyzine
75 mg
Placebo Comparator: Lactose
Groups placebo : 4 g de lactose
Drug: Lactose
4 g


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01675986

Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Principal Investigator: Bertrand DEBAENE, MD Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital Identifier: NCT01675986     History of Changes
Other Study ID Numbers: GABAPAC
Study First Received: February 7, 2012
Last Updated: October 10, 2016

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents processed this record on August 18, 2017