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Completed

NCT Number: NCT02152176

Morphine Titration by Patient Self-controlled by a Mechanical Device Versus Administration by the Nurse for Patients With Severe Acute Pain in the Emergency Department

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).

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Key information

Conditions

Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SCHOTTE Thibault, Angers, France

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Who can participate

Healthy volunteers accepted: No

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

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
  • Uncontrolled epilepsy
  • Pregnant or lactating
  • Patient jailed
  • Incapacitated adult under guardianship
  • Incapable of giving informed consent

Treatment and study plan

Titration of morphine by Patient Controlled Analgesy

Device

PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.

Primary outcomes

  1. 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

  1. Evaluate the effectiveness in the group Patient Controlled Analgesy

    Time frame: 4h

    • time to obtain effective analgesia from prescirption
    • consumption of morphine
    • Visual Analog Scale evolution
    • percentage of patients relieved defined by VAS <40, 1 hour after the prescription of opioid titration

  2. Satisfaction

    Time frame: 4h

    • patient satisfaction
    • nurse satisfaction
    • time to prepare morphine titration

Other outcomes

  1. Assess the safety in the group Patient Controlled Analgesy

    Time frame: 4h

    • adverse events du to morphine
    • adverse events du to medical/nursing support

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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.

Acronym: TACIDOU

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2014
Registry last updated
Jun 30, 2016

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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