Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Pregabaline Groups PREGABALINE : 150 mg de LYRICA® |
Drug: Pregabalin
150 mg
|
Experimental: Hydroxyzine Groups HYDROXYZINE : 75 mg d'ATARAX® |
Drug: hydroxyzine
75 mg
|
Placebo Comparator: Lactose Groups placebo : 4 g de lactose |
Drug: Lactose
4 g
|
Outcome Measures
Primary Outcome Measures
- Efficacy treatment []
anxiety score VAS: 0 to 100
Secondary Outcome Measures
- Efficacy of pregabaldin []
anxiety score VAS:0 to 100
Eligibility Criteria
Criteria
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
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Hypersensitivity to hydroxyzine, one of its metabolites, one of the excipients, another derivative of piperazine, aminophylline or ethylene diamine.
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Patient at risk of glaucoma e
-
Patient at risk for urinary retention
-
Patient severe respiratory failure
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Patient at the general condition not too corrupted (ASA IV)
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Renal failure with creatinin clearance < 30 ml / min
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Patient not affiliated to Social Security
-
Pregnant or lactating
-
Patients in emergency situations
-
Inpatient without consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | CHU de POITIERS | Poitiers | France | 86021 |
Sponsors and Collaborators
- Poitiers University Hospital
Investigators
- Principal Investigator: Bertrand DEBAENE, MD, Poitiers University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GABAPAC