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Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01675986
First received: February 7, 2012
Last updated: October 10, 2016
Last verified: October 2016
History of Changes

February 7, 2012
October 10, 2016
Not Provided
November 2014   (Final data collection date for primary outcome measure)
Efficacy treatment
anxiety score VAS: 0 to 100
Same as current
Complete list of historical versions of study NCT01675986 on ClinicalTrials.gov Archive Site
Efficacy of pregabaldin
anxiety score VAS:0 to 100
Same as current
Not Provided
Not Provided
 
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
Not Provided

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.
Not Provided
Interventional
Phase 2
Not Provided
Feeling Anxious
  • Drug: hydroxyzine
    75 mg
  • Drug: Pregabalin
    150 mg
  • Drug: Lactose
    4 g
  • Experimental: Pregabaline
    Groups PREGABALINE : 150 mg de LYRICA®
    Intervention: Drug: Pregabalin
  • Experimental: Hydroxyzine
    Groups HYDROXYZINE : 75 mg d'ATARAX®
    Intervention: Drug: hydroxyzine
  • Placebo Comparator: Lactose
    Groups placebo : 4 g de lactose
    Intervention: Drug: Lactose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
Not Provided
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01675986
GABAPAC
Not Provided
Not Provided
Not Provided
Not Provided
Poitiers University Hospital
Poitiers University Hospital
Not Provided
Principal Investigator: Bertrand DEBAENE, MD Poitiers University Hospital
Poitiers University Hospital
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP