Overview

Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Poitiers University Hospital
Treatments:
Hydroxyzine
Pregabalin
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

- 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