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Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01675986
First Posted: August 30, 2012
Last Update Posted: October 11, 2016
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.
Information provided by (Responsible Party):
Poitiers University Hospital
  Purpose

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

  Eligibility

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

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
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 ClinicalTrials.gov identifier (NCT number): NCT01675986


Locations
France
CHU de POITIERS
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Bertrand DEBAENE, MD Poitiers University Hospital
  More Information

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01675986     History of Changes
Other Study ID Numbers: GABAPAC
First Submitted: February 7, 2012
First Posted: August 30, 2012
Last Update Posted: October 11, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Pregabalin
Hydroxyzine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents