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Completed

NCT Number: 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.

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Key information

Conditions

Feeling Anxious Anxiety Disorders Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de POITIERS

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydroxyzine

Drug

75 mg

Pregabalin

Drug

150 mg

lactose

Drug

4 g

Primary outcomes

  1. Efficacy treatment

    anxiety score VAS: 0 to 100

Secondary outcomes

  1. Efficacy of pregabaldin

    anxiety score VAS:0 to 100

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Primary completion
2014
First posted
Aug 30, 2012
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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