Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01675986
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : October 11, 2016
Information provided by (Responsible Party):
Poitiers University Hospital

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.

Condition or disease Intervention/treatment Phase
Feeling Anxious Drug: hydroxyzine Drug: Pregabalin Drug: Lactose Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 306 participants
Actual Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01675986

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

Responsible Party: Poitiers University Hospital Identifier: NCT01675986     History of Changes
Other Study ID Numbers: GABAPAC
First Posted: August 30, 2012    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 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