Status:

COMPLETED

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

Lead Sponsor:

University Hospital, Toulouse

Conditions:

Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief 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 t...

Detailed Description

Obtaining high-quality analgesia in prehospital patients with severe pain is an important treatment objective for medical team. Opioids are recognized as the treatment of choice for relief of severe a...

Eligibility Criteria

Inclusion

  • Patient aged 18 years or older
  • Patient with a severe traumatic acute pain defined by an NRS score of 6/10 or higher at randomization.

Exclusion

  • Patient-reported history of chronic respiratory, renal, or hepatic insufficiency
  • Patient known opioid or hydroxyzine allergies
  • recent treatment with opioids or anxiolytics
  • incapacity to understand the NRS
  • hypotension (defined as a systolic blood pressure \<90 mm Hg,bradypnea of less than 12/min, oxygen desaturation of less than 90%, seizures or a Glasgow Coma Scale score of less than 14)
  • pregnancy
  • drug addiction
  • Patient who had already received a morphinic (within 6 hours) or anxiolitic

Key Trial Info

Start Date :

May 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

140 Patients enrolled

Trial Details

Trial ID

NCT01151696

Start Date

May 1 2010

End Date

January 1 2014

Last Update

July 23 2014

Active Locations (1)

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1

Universty Hospital Toulouse SAMU 31

Toulouse, France, 31059