Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Phase 2

Completed

• Conditions: Feeling Anxious
• Interventions: Drug: hydroxyzine; Drug: Lactose; Drug: Pregabalin

• Registration Number: NCT01675986
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-07
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Primary Completion: 2014-11
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hydroxyzine	hydroxyzine	Groups HYDROXYZINE : 75 mg d'ATARAX®
Lactose	Lactose	Groups placebo : 4 g de lactose
Pregabaline	Pregabalin	Groups PREGABALINE : 150 mg de LYRICA®

Primary Outcome Measures

Name	Time	Method
Efficacy treatment		anxiety score VAS: 0 to 100

Secondary Outcome Measures

Name	Time	Method
Efficacy of pregabaldin		anxiety score VAS:0 to 100

Trial Locations

Locations (1)

CHU de POITIERS; 🇫🇷 Poitiers, France