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

NCT01151696 | Completed Phase 4

• 2 other identifiers: 09187032009-015529-35
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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

Pain

Keywords

Pain; morphine; hydroxyzine; acute pain; traumatic pain; anxiety; post trauma stress; post trauma anxiety; post trauma disorders

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with pain relief (with a NRS score of 3/10 or lower)

  15 minutes after the first injection

Secondary Outcomes (6)

• pain score comparisons

  every 5 minutes within the first 30 minutes

• pain and anxiety comparisons

  15 minutes after the first injection

• comparison of adverse events

  one hour after the first injection

• patient and investigator satisfaction with analgesia

  30 minutes after the firest injection

• assessment of post traumatic anxiety, stress and other related disorders

  2 days

Study Arms (2)

hydroxyzine

EXPERIMENTAL

Patients will receive intravenous hydroxyzine 1mg/kg at the beginning of the morphine titration protocol, and intravenous morphine 0.15 mg/kg then 0.05 mg/kg if necessary, every 5 minutes.

Drug: Atarax (Hydroxyzine)

Placebo

PLACEBO COMPARATOR

Patients will receive intravenous placebo at the beginning of the morphine titration protocol, and intravenous morphine 0.15 mg/kg then 0.05 mg/kg if necessary, every 5 minutes.

Drug: Placebo

Interventions

Atarax (Hydroxyzine) DRUG

One milligram per 10 kilogram, intramuscular use

hydroxyzine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Universty Hospital Toulouse SAMU 31

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Pain; Acute Pain; Anxiety Disorders

Interventions

Hydroxyzine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean-Louis DUCASSE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 28, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: January 1, 2014
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

FR (1)