Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Poitiers University Hospital

Status and phase

Completed

Phase 2

Conditions

Feeling Anxious

Treatments

Drug: Pregabalin

Drug: hydroxyzine

Drug: Lactose

Study type

Interventional

Funder types

Other

Identifiers

NCT01675986

GABAPAC

Details and patient eligibility

About

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.

Enrollment

306 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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