Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
NCT ID: NCT01675986
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
306 participants
INTERVENTIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
NCT00368745
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT00624780
Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).
NCT00413010
Effect on Anxiety in Partial Epilepsy Patients Treated With Pregabalin
NCT01128712
Analgetic and Anxiolytic Effect of Preoperative Pregabalin
NCT00353704
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pregabaline
Groups PREGABALINE : 150 mg de LYRICA®
Pregabalin
150 mg
Hydroxyzine
Groups HYDROXYZINE : 75 mg d'ATARAX®
hydroxyzine
75 mg
Lactose
Groups placebo : 4 g de lactose
Lactose
4 g
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hydroxyzine
75 mg
Pregabalin
150 mg
Lactose
4 g
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient schedules for insertion of long-lasting intravenous device
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Poitiers University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bertrand DEBAENE, MD
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de POITIERS
Poitiers, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GABAPAC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.