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

Acute Pain Clinical Trial

— TACIDOU  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152176
• Other study ID #: AOI 2013-08
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2014
• Last updated: June 29, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.

Locations

Country	Name	City	State
France	SCHOTTE Thibault	Angers
France	CHOUKROUN Jacques	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess the safety in the group Patient Controlled Analgesy	adverse events du to morphine; adverse events du to medical/nursing support	4h	Yes
Primary	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	No
Secondary	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	No
Secondary	Satisfaction	patient satisfaction; nurse satisfaction; time to prepare morphine titration	4h	No