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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabaline | Experimental | Groups PREGABALINE : 150 mg de LYRICA® |
|
| Hydroxyzine | Experimental | Groups HYDROXYZINE : 75 mg d'ATARAX® |
|
| Lactose | Placebo Comparator | Groups placebo : 4 g de lactose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydroxyzine | Drug | 75 mg |
| |
| Pregabalin |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy treatment | anxiety score VAS: 0 to 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of pregabaldin | anxiety score VAS:0 to 100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertrand DEBAENE, MD | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de POITIERS | Poitiers | 86021 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D000069583 | Pregabalin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
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| Drug |
150 mg |
|
| Lactose | Drug | 4 g |
|
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |