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 (TACIDOU)
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|ClinicalTrials.gov Identifier: NCT02152176|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 30, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Device: Titration of morphine by Patient Controlled Analgesy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||July 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Patient Controlled Analgesy group
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
PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.
No Intervention: Control group
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
- 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')
- 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
- Satisfaction [ Time Frame: 4h ]
- patient satisfaction
- nurse satisfaction
- time to prepare morphine titration
- Assess the safety in the group Patient Controlled Analgesy [ Time Frame: 4h ]
- adverse events du to morphine
- adverse events du to medical/nursing support
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152176
|Angers, France, 49933|
|Le Mans, France|
|Study Chair:||ROY Pierre-Marie, MD-PhD||UH Angers|
|Principal Investigator:||SCHOTTE Thibault, Physician||UH Angers|