Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
|ClinicalTrials.gov Identifier: NCT01675986|
Recruitment Status : Completed
First Posted : August 30, 2012
Last Update Posted : October 11, 2016
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|
|Primary Completion Date :||November 2014|
Groups PREGABALINE : 150 mg de LYRICA®
Groups HYDROXYZINE : 75 mg d'ATARAX®
Placebo Comparator: Lactose
Groups placebo : 4 g de lactose
- Efficacy treatmentanxiety score VAS: 0 to 100
- Efficacy of pregabaldinanxiety score VAS:0 to 100
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675986
|CHU de POITIERS|
|Poitiers, France, 86021|
|Principal Investigator:||Bertrand DEBAENE, MD||Poitiers University Hospital|