Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675986

Enrollment

306

Registered

2012-08-30

Start date

Unknown

Completion date

Unknown

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeling Anxious

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.

Interventions

DRUGhydroxyzine

75 mg

DRUGPregabalin

150 mg

DRUGLactose

4 g

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy treatment	—	anxiety score VAS: 0 to 100

Secondary

Measure	Time frame	Description
Efficacy of pregabaldin	—	anxiety score VAS:0 to 100

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026