Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Tracking Information
First Submitted Date ICMJE	February 7, 2012
First Posted Date ICMJE	August 30, 2012
Last Update Posted Date	October 11, 2016
Study Start Date ICMJE	Not Provided
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 29, 2012)	Efficacy treatment; anxiety score VAS: 0 to 100
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01675986 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 29, 2012)	Efficacy of pregabaldin; anxiety score VAS:0 to 100
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
Official Title ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Not Provided
Condition ICMJE	Feeling Anxious
Intervention ICMJE	Drug: hydroxyzine 75 mg; Drug: Pregabalin 150 mg; Drug: Lactose 4 g
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 10, 2016)	306
Original Enrollment ICMJE	Not Provided
Study Completion Date	Not Provided
Actual Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01675986
Other Study ID Numbers ICMJE	GABAPAC
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Poitiers University Hospital
Study Sponsor ICMJE	Poitiers University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Bertrand DEBAENE, MD Poitiers University Hospital
PRS Account	Poitiers University Hospital
Verification Date	October 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP