Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
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|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|
|Actual 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
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
|CHU de POITIERS|
|Poitiers, France, 86021|
|Principal Investigator:||Bertrand DEBAENE, MD||Poitiers University Hospital|