Acute PainPhase 4TACIDOUNCT02152176
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
A Phase 4 study of Acute Pain, run by University Hospital, Angers at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2014to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to an emergency department
- Acute pain (Visual Analog Scale > 60)
- Able to assess pain using the numerical scale
- Prescription of morphine titration
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
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.
Read more
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).
- Conditions
- Acute Pain
- Being tested
- Titration of morphine by Patient Controlled Analgesy
- Keywords
- pain, analgesia, morphine, PCA, Nurse
- Medical subject headings
- Acute Pain, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of morphine by Patient Controlled AnalgesyDevice
PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patient Controlled Analgesy group | Experimental | 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. Receives: Device: Titration of morphine by Patient Controlled Analgesy |
| Control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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')
Measured: 30min
Secondary outcomes (2)
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
Measured: 4h
Satisfaction
- patient satisfaction
- nurse satisfaction
- time to prepare morphine titration
Measured: 4h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ROY Pierre-Marie, MD-PhD, Study chair, UH AngersSCHOTTE Thibault, Physician, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152176
- Sponsor's protocol ID
- AOI 2013-08
- Acronym
- TACIDOU
- Status last verified
- Jun 2016
- First submitted
- 22 May 2014
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02152176
- Acronym / sponsor ID
- TACIDOU / AOI 2013-08
- Conditions
- Acute Pain
- Keywords
- pain, analgesia, morphine, PCA, Nurse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Controlled Analgesy group | Experimental | Device: Titration of morphine by Patient Controlled AnalgesyTitration 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. |
| Control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission to an emergency department
- Acute pain (Visual Analog Scale > 60)
- Able to assess pain using the numerical scale
- Prescription of morphine titration
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of morphine by Patient Controlled AnalgesyPCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention. | Device | Patient Controlled Analgesy group |
Primary outcome
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')
2 secondary outcomes
Evaluate the effectiveness in the group Patient Controlled Analgesy
Time frame: 4h
Satisfaction
Time frame: 4h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROY Pierre-Marie, MD-PhD study chair
UH Angers
SCHOTTE Thibault, Physician principal investigator
UH Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Acute Pain, run by University Hospital, Angers at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale <30 (time frame: 30min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.