Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Feeling Anxious Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675986
• Other study ID #: GABAPAC
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2012
• Last updated: October 10, 2016

Study information

• Verified date: October 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Feeling Anxious

Intervention

Drug:
• hydroxyzine
75 mg
• Pregabalin
150 mg
• Lactose
4 g

Locations

Country	Name	City	State
France	CHU de POITIERS	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy treatment	anxiety score VAS: 0 to 100
Secondary	Efficacy of pregabaldin	anxiety score VAS:0 to 100