- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675986
Comparing the Efficacy of Pregabalin and Hydroxyzine on the Anxiety Score
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Poitiers, France, 86021
- CHU de Poitiers
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pregabaline
Groups PREGABALINE : 150 mg de LYRICA®
|
150 mg
|
Experimental: Hydroxyzine
Groups HYDROXYZINE : 75 mg d'ATARAX®
|
75 mg
|
Placebo Comparator: Lactose
Groups placebo : 4 g de lactose
|
4 g
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Efficacy treatment
|
anxiety score VAS: 0 to 100
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Efficacy of pregabaldin
|
anxiety score VAS:0 to 100
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bertrand DEBAENE, MD, Poitiers university hospital
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Dermatologic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- Anti-Anxiety Agents
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Pregabalin
- Hydroxyzine
Other Study ID Numbers
- GABAPAC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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