Clinical trial 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
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: pain
analgesia
morphine
PCA
Nurse
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-06-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Visual Analog Scale <30
timeFrame: 30min
Secondary outcomes:
measure: Evaluate the effectiveness in the group Patient Controlled Analgesy
timeFrame: 4h
measure: Satisfaction
timeFrame: 4h
Other outcomes:
measure: Assess the safety in the group Patient Controlled Analgesy
timeFrame: 4h
Locations:
city: Angers
country: France
facility: SCHOTTE Thibault
city: Le Mans
country: France
facility: CHOUKROUN Jacques
Study officials:
affiliation: UH Angers
name: ROY Pierre-Marie, MD-PhD
role: STUDY_CHAIR
affiliation: UH Angers
name: SCHOTTE Thibault, Physician
role: PRINCIPAL_INVESTIGATOR
References: