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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: Hydroxyzine; Morphine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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