Severe, Acute Pain in a Pre-hospital SettingPhase 4NCT00237731
Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
A Phase 4 study testing morphine in people with Severe, Acute Pain in a Pre-hospital Setting, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe, Acute Pain in a Pre-hospital Setting
- What is being tested?
- morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Mar 2006
- 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
- Severe, acute pain defined by a VRS of 60/100 or higher
- Male or female over 18 years
- Cared by a medical emergency care unit
- Written informed consent
- Affiliated to social security
Who cannot join
- A known opioid or paracetamol hypersensitivity
- Patient not agree ta participate at the study
- Pregnancy
- Uncontrolled epilepsia
- Incapacity to understand the VRS
- Renal, respiratory, or liver disease
Show all 11Show fewer
- Patients who have received sedative drugs or alcohol (< 6h)
- Acute respiratory, haemodynamic or neurologic failure
- Patients who have already received an analgesic (< 6h)
- Drug addiction
- Patients under protection of justice
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg
Read the detailed description
STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be followed during the study until 60 minutes.
- Being tested
- morphine
- Keywords
- Acute pain, Morphine titration, Analgesia, Pre-hospital care
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | morphine 0.05 Receives: Drug: morphine |
| 2 | Active comparator | morphine 0.10 Receives: Drug: morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
Secondary outcomes (4)
Time to obtain an analgesia, defined by a VRS < or = 30
Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Safety evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe, Acute Pain in a Pre-hospital SettingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Louis DUCASSE, Principal investigator, University Hospital, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237731
- Sponsor's protocol ID
- 0505103
- Status last verified
- May 2017
- First submitted
- 7 Oct 2005
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine]. Ann Fr Anesth Reanim. 1997;16(8):945-9. doi: 10.1016/s0750-7658(97)82142-9. French.
PubMed 9750642Ricard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22
SFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51
SFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7
Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.
PubMed 18272093
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg
- ClinicalTrials.gov ID
- NCT00237731
- Acronym / sponsor ID
- 0505103
- Keywords
- Acute pain, Morphine titration, Analgesia, Pre-hospital care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 12 Oct 2005 (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.
Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg
Detailed description
STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be followed during the study until 60 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: morphinemorphine 0.05 |
| 2 | Active comparator | Drug: morphinemorphine 0.10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Severe, acute pain defined by a VRS of 60/100 or higher
- Male or female over 18 years
- Cared by a medical emergency care unit
- Written informed consent
- Affiliated to social security
Key exclusion criteria (11 listed)
- A known opioid or paracetamol hypersensitivity
- Patient not agree ta participate at the study
- Pregnancy
- Uncontrolled epilepsia
- Incapacity to understand the VRS
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 |
|---|---|---|
| morphinemorphine 0.05 | Drug | 1 |
| morphinemorphine 0.10 | Drug | 2 |
Primary outcome
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration
4 secondary outcomes
Time to obtain an analgesia, defined by a VRS < or = 30
Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)
Safety evaluation
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 12 May 2017.
- Background: PubMed 9750642Ricard-Hibon A, Leroy N, Magne M, Leberre A, Chollet C, Marty J. [Evaluation of acute pain in prehospital medicine]. Ann Fr Anesth Reanim. 1997;16(8):945-9. doi: 10.1016/s0750-7658(97)82142-9. French.
- BackgroundRicard-Hibon A, Marty J. Prise en charge de la douleur en milieu préhospitalier, In SFAR, Conférences d'actualisation 2001, Paris, Elsevier,2001;pp 709-22
- BackgroundSFAR. Quelles sont les modalités de réalisation d'une sédation et/ou d'une analgésie du malade en ventilation spontanée. In : SFAR eds. Modalités de la sédation et/ou de l'analgésie en situation extrahospitalière : Conférence d'experts. Paris, Elsevier;2000;pp 37-51
- BackgroundSFUM. Troisième conférence de consensus en médecine d'urgence de la Société francophone d'urgence médicale. Le traitement médicamenteux de la douleur de l'adulte dans un service d'accueil et d'urgence. Réan Urg 1993; 2:321-7
- Results publication: PubMed 18272093Bounes V, Charpentier S, Houze-Cerfon CH, Bellard C, Ducasse JL. Is there an ideal morphine dose for prehospital treatment of severe acute pain? A randomized, double-blind comparison of 2 doses. Am J Emerg Med. 2008 Feb;26(2):148-54. doi: 10.1016/j.ajem.2007.04.020.
- Observatoire Régional Urgences Midi-Pyrénées, Rapport annuel sur l'activité des services d'urgence 2004Link provided by the sponsor.
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.
Jean-Louis DUCASSE principal investigator
University Hospital, Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing morphine in people with Severe, Acute Pain in a Pre-hospital Setting, run by University Hospital, Toulouse at 1 site 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 5 inclusion and 11 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 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00237731, which also lists 5 linked publications.
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 12 May 2017.