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Pain and Anxiety Management of Traumatic Emergency in a Pre-hospital Setting

NCT01151696 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2014-07-23

No results posted yet for this study

Summary

Unexpected acute pain in an emergency setting causes anxiety, insecurity, and stress that can diminish perceptions of control over pain and diminish ability to decrease pain. This may interfere with the opioid treatment and poses the question of whether an anxiolytic drug added to the morphine titration could relief pain and/or anxiety. This randomized double-blind group clinical trial is designed to determine the efficacy and safety of hydroxyzine in addition to a conventional intravenous morphine titration protocol.

Conditions

Interventions

DRUG

Atarax (Hydroxyzine)

One milligram per 10 kilogram, intramuscular use

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Jean-Louis DUCASSE, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-09-30
Completion
2014-01-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01151696 on ClinicalTrials.gov