Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01675986
Collaborator
(none)
306
1
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
306 participants
Actual Primary Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregabaline

Groups PREGABALINE : 150 mg de LYRICA®

Drug: Pregabalin
150 mg

Experimental: Hydroxyzine

Groups HYDROXYZINE : 75 mg d'ATARAX®

Drug: hydroxyzine
75 mg

Placebo Comparator: Lactose

Groups placebo : 4 g de lactose

Drug: Lactose
4 g

Outcome Measures

Primary Outcome Measures

  1. Efficacy treatment []

    anxiety score VAS: 0 to 100

Secondary Outcome Measures

  1. Efficacy of pregabaldin []

    anxiety score VAS:0 to 100

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de POITIERS Poitiers France 86021

Sponsors and Collaborators

  • Poitiers University Hospital

Investigators

  • Principal Investigator: Bertrand DEBAENE, MD, Poitiers University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Poitiers University Hospital
ClinicalTrials.gov Identifier:
NCT01675986
Other Study ID Numbers:
  • GABAPAC
First Posted:
Aug 30, 2012
Last Update Posted:
Oct 11, 2016
Last Verified:
Oct 1, 2016
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2016