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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01151696
• Date of registration: 25/06/2010
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Pain and Anxiety Management of Traumatic Emergency in a Pre-hospital Setting
• Scientific title: Prise en Charge Pharmacologique de l'anxiété et de la Douleur Chez Les Patients Qui Souffrent en Situation d'Urgence Traumatique pré-hospitalière : étude randomisée contrôlée en Double Aveugle
• Date of first enrolment: May 2010
• Target sample size: 140
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01151696
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Jean-Louis DUCASSE, MD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Placebo

Drug: Atarax (Hydroxyzine)

Primary Outcome(s)

Percentage of patients with pain relief (with a NRS score of 3/10 or lower) [Time Frame: 15 minutes after the first injection]

Secondary Outcome(s)

comparison of adverse events [Time Frame: one hour after the first injection]

pain score comparisons [Time Frame: every 5 minutes within the first 30 minutes]

patient and investigator satisfaction with analgesia [Time Frame: 30 minutes after the firest injection]

assessment of post traumatic anxiety, stress and other related disorders [Time Frame: 3 weeks]

pain and anxiety comparisons [Time Frame: 15 minutes after the first injection]

assessment of post traumatic anxiety, stress and other related disorders [Time Frame: 2 days]

Secondary ID(s)

0918703

2009-015529-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors