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Clinical Trials/NCT02152176
NCT02152176
Completed
Phase 4

Titration Morphinique autocontrôlée Par le Patient Par un Dispositif mécanique à Usage Unique Versus Administration Par l'infirmière Chez Les Patients Ayant Une Douleur aiguë sévère Aux Urgences.

University Hospital, Angers2 sites in 1 country200 target enrollmentJuly 2014
ConditionsAcute Pain

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Acute Pain
Sponsor
University Hospital, Angers
Enrollment
200
Locations
2
Primary Endpoint
Visual Analog Scale <30
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Intense acute pain is a common reason for Emergency admittance and its management is one of the major public health goals.

In the recommendations formalized experts, it is recommended to use a protocol titration with morphine bolus of 2 mg (for patients less than 60 kg) or 3 mg (for patients over 60 kg) repeated every 5 minutes with a target of the Visual Analog Scale less than or equal to 30.

Despite these specific recommendations and a broad awareness of the teams, management of pain remains to be improved, the major difficulty of morphine titration at the emergency department being the availability of paramedical personnel to perform revaluations and reinjection. Thus, effective analgesia would be obtained in 50% of cases to 30 minutes.

The investigators want to study the self-controlled morphine titration by the patient by a mechanical device for single use (efficacy/safety).

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
February 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Admission to an emergency department
  • Acute pain (Visual Analog Scale \> 60)
  • Able to assess pain using the numerical scale
  • Prescription of morphine titration

Exclusion Criteria

  • Physical or mental disorders limiting the understanding and / or use of a PCA
  • History of allergy to morphine / hypersensitivity to any component
  • Long-term treatment morphine
  • Opioid therapy administered prior to inclusion
  • Analgesic treatment level 2 (codeine, tramadol, nefopam ...) administered prior to inclusion or planned
  • History of Substance Abuse
  • Severe respiratory insufficiency
  • Severe hepatic impairment
  • Head trauma
  • Intracranial hypertension

Outcomes

Primary Outcomes

Visual Analog Scale <30

Time Frame: 30min

Evaluate the effectiveness of the analgesia of morphine titration self-controlled by the patient using a PCA device for single use ("PCA" group) opposing to an opioid titration carried out by the nurse (group 'Control')

Secondary Outcomes

  • Evaluate the effectiveness in the group Patient Controlled Analgesy(4h)
  • Satisfaction(4h)

Study Sites (2)

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