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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01151696
First received: June 25, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Atarax (Hydroxyzine)
Drug: Placebo
Phase 4

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
Official 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • Percentage of patients with pain relief (with a NRS score of 3/10 or lower) [ Time Frame: 15 minutes after the first injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain score comparisons [ Time Frame: every 5 minutes within the first 30 minutes ] [ Designated as safety issue: No ]
  • pain and anxiety comparisons [ Time Frame: 15 minutes after the first injection ] [ Designated as safety issue: No ]
  • comparison of adverse events [ Time Frame: one hour after the first injection ] [ Designated as safety issue: No ]
  • patient and investigator satisfaction with analgesia [ Time Frame: 30 minutes after the firest injection ] [ Designated as safety issue: No ]
  • assessment of post traumatic anxiety, stress and other related disorders [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • assessment of post traumatic anxiety, stress and other related disorders [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: May 2010
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydroxyzine
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)
One milligram per 10 kilogram, intramuscular use
Placebo Comparator: Placebo
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
Placebo

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 acute pain. Recommended initial analgesia of patients with severe acute pain, defined as a numerical rating scale (NRS) score of 6/10 or higher, in a prehospital setting in France consists of the administration of morphine by the medical staff of mobile intensive care units. The intravenous administration of morphine is usually considered as the gold standard for any emergency setting. Nevertheless, even when using high dose boluses and aggressive titration protocols, pain relief remains inconsistent for some patients. Moreover, 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.There is no study, to our knowledge, assessing the clinical efficacy of hydroxyzine added to the morphine in a prehospital setting. Hydroxyzine is used primarily as an antihistamine drug for the treatment of itching, allergies, motion sickness-induced nausea, and insomnia, as well as notably for the treatment of mild 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 by comparing hydroxyzine and placebo for medical prehospital treatment of adult patients with severe traumatic acute pain. Eligible patients with a numerical rating scale (NRS) score of 6/10 or higher will be randomly allocated to receive either hydroxyzine 1mg/kg at inclusion (group A) or an intravenous placebo. The intravenous morphine analgesia will be given and titrated according to the pain score every 5 minutes. The drugs will be administered by the physician from syringes of similar appearance prepared by the nurse who is not otherwise involved in the study. The protocol-defined primary outcome measure is the percentage of patients with pain relief (with a NRS score of 3/10 or lower) 15 minutes after the first injection. Secondary outcomes include pain score comparisons every 5 minutes within the first 30 minutes and comparison of adverse events. The physician blinded to the analgesic treatment groups will do all assessments of patients. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (Spo2), and a sedation scale (0, patient is awake; 1, patient is with intermittent sleeping; 2, patient is sleeping, awakened by verbal stimulation; 3, patient is sleeping, awakened by tactile stimulation; 4, patient is not aroused by stimulation) at these periods. Fifteen minutes after the first injection, overall patient and investigator satisfaction with analgesia will be recorded. Moreover, several assessments will be done by psychologists 2 and 21 days after the trauma, including post traumatic stress and anxiety levels.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151696

Locations
France
Universty Hospital Toulouse SAMU 31
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Jean-Louis DUCASSE, MD University Hospital, Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01151696     History of Changes
Other Study ID Numbers: 0918703, 2009-015529-35
Study First Received: June 25, 2010
Last Updated: July 22, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
Pain
morphine
hydroxyzine
acute pain
traumatic pain
anxiety
post trauma stress
post trauma anxiety
post trauma disorders

Additional relevant MeSH terms:
Hydroxyzine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014