Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Poitiers University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01675986
First received: February 7, 2012
Last updated: March 27, 2013
Last verified: February 2012
  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


Estimated Primary Completion Date: January 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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675986

Contacts
Contact: Bertrand DEBAENE, MD 0549443895 bertrand.debaene@chu-poitiers.fr

Locations
France
CHU de POITIERS Recruiting
Poitiers, France, 86021
Contact: Bertrand Debaene    0549443895      
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Principal Investigator: Bertrand DEBAENE, MD Poitiers University Hospital
  More Information

No publications provided

Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT01675986     History of Changes
Other Study ID Numbers: GABAPAC
Study First Received: February 7, 2012
Last Updated: March 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pregabalin
Hydroxyzine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014