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Completed

NCT Number: NCT03380247

Multimodal Oral Analgesia for Trauma in the Emergency Department

The prevalence of pain in the emergency department is estimated between 60% and 78%. However, many studies reported oligo analgesia in about half of patient admitted to the emergency department. The delay before effective analgesia is one of the main causes of oligoanalgesia. The use of nurse-directed protocol allows the administration of analgesic upon admission to the emergency department. Nevertheless the need of intravenous access may delay analgesia. The use of oral form analgesics even with immediate release does not allow effective analgesia before 20 min. Pain management protocol in the emergency reception desk of CHU Grenoble Alpes (CHUGA) includes paracetamol that can be combined with oxycodone tablets depending on the pain intensity. For any mono traumatized it is possible to associate self-administer methoxyflurane inhaler. The pain management protocol is already used in the emergency reception desk of CHU Grenoble Alpes.The different analgesics( paracetamol,oral oxycodone, methoxyflurane) are already administered as part of routine care.The use of these different analgesics means would allow a rapid and adapted effectiveness to the pain intensity. However, there are no data on the efficacy and acceptability of such an early multimodal analgesia protocol in the emergency department.

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Key information

Conditions

Pain Agnosia Disease Attributes Emergencies Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency Department of University Hospital Grenoble

Grenoble, Auvergne Rhonalpes, 38043, France

About this study

200 Patients will be included from 8:00 am to 8:00 pm and will receive a multimodal analgesia under the nurse-directed pain management protocol (paracetamol +/- oral oxycodone +/- methoxyflurane) as part of routine medical care.

The pain will be evaluated (Numerical rating scale) prior to the administration and reassessed by a nurse every 5 minutes for 30 minutes and then at 45min and 1 hour after administration of the pain protocol. Satisfaction of patients and caregivers will also be assessed at the end of care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients : ≥ 18 year and older
  • Trauma pain
  • NRS≥ 4
  • Non- opposition to participate in the study

Exclusion criteria

  • Trauma with at least one of the following severity criteria:
  • Suspected (from mechanism) or confirmed multiple trauma
  • State of shock
  • Suspected or proven trauma to the thorax (excluding isolated rib fractures with Spo2 ≥ 98%)
  • Suspected or proven Abdominal trauma
  • Suspected or proven pelvic trauma
  • Severe traumatic brain injury
  • Altered level of consciousness (Glasgow score < 15)
  • Patients who took any analgesic within 4 hours prior to admission (except paracetamol)
  • Use of nitrous oxide in the hour before admission
  • Patient requiring an intravenous access at admission (e.g. : open fracture displaced)
  • Hypersensitivity to one of the molecules of the analgesia protocol
  • Known pregnant or likely to be pregnant women at the time of inclusion
  • Subject in an exclusion period from another study
  • Subjects under tutelage or subjects deprived of liberty
  • Patients to be unable to understand the purpose of study

Treatment and study plan

Primary outcomes

  1. Proportion of patients with a score of less than or equal to 3 on a pain Numeric Rating scale (NRS) (0-10) 15 minutes after inclusion

    Time frame: 15 minutes after inclusion

    NRS scale (0-10)

Secondary outcomes

  1. Secondary efficacy criteria

    Time frame: 15, 30 and 45 min (after inclusion)

    Delay of pain relief defined by a 2 point reduction in the NRS scale (0-10)

  2. Number of patient with 30% reduction in pain intensity

    Time frame: 15,30 and 45 min (after inclusion)

    NRS scale (0-10)

  3. Satisfaction of caregiver and patient

    Time frame: 1h after inclusion

    Patient and caregiver satisfaction evaluated by a visual analog scale (VAS), covering the whole range of analgesic management and in particular each component of multimodal analgesia. The VAS scale ranges are : (not at all satisfied I will not take again - quite satisfied i will take again) for the patient and (not at all satisfied i will not give again - quite satisfied i will give again) for the caregiver

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Mundipharma Pte Ltd.

Registry information

Official study title

Multimodal Oral Analgesia for Trauma in the Emergency Department: a Prospective Observational Study of a Nurse-directed Protocol

Acronym: START

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 21, 2017
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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