A Phase 4 interventional study of Titration of morphine by Patient Controlled Analgesy in Acute Pain, sponsored by University Hospital, Angers. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-30.
Sponsored by University Hospital, Angers · Phase 4, Interventional, and Treatment
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).
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 200 is above the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.
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')
Time frame: 30min
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
Time frame: 4h
Satisfaction
* patient satisfaction * nurse satisfaction * time to prepare morphine titration
Time frame: 4h
Assess the safety in the group Patient Controlled Analgesy
* adverse events du to morphine * adverse events du to medical/nursing support
Time frame: 4h
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Angers