Skip to content

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

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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02152176
Acronym
TACIDOU
Enrollment
200
Registered
2014-06-02
Start date
2014-07-31
Completion date
2016-02-29
Last updated
2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

pain, analgesia, morphine, PCA, Nurse

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).

Interventions

DEVICETitration 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.

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale <3030minEvaluate 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')

Secondary

MeasureTime frameDescription
Evaluate the effectiveness in the group Patient Controlled Analgesy4h* 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
Satisfaction4h* patient satisfaction * nurse satisfaction * time to prepare morphine titration

Other

MeasureTime frameDescription
Assess the safety in the group Patient Controlled Analgesy4h* adverse events du to morphine * adverse events du to medical/nursing support

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026