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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Acute Pain

Intervention / Treatment
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* Device: Titration of morphine by Patient Controlled Analgesy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Controlled Analgesy group<br>Titration of morphine by Patient Controlled Analgesy. The opioid titration will be performed by the patient using PCA (Vygon Freedom 5) according to the principle of self with a refractory period of 5 minutes. | Device: Titration of morphine by Patient Controlled Analgesy<br>* PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.<br>|
| No Intervention: Control group<br>titration will be perform in the usual manner in accordance with the recommendations : a nurse will assess pain using a visual analog scale in the control group to assess the need for a new bolus of morphine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale <30 | 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') | 30min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness in the group Patient Controlled Analgesy | 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 | 4h | 
| Satisfaction | patient satisfaction nurse satisfaction time to prepare morphine titration | 4h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, analgesia, morphine, PCA, Nurse