Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
242
Countries
1
Sites
5
Severe pain
To compare the analgesic efficacy 15 minutes after intravenous injection of morphine or alfentanil in adults with severe acute pain (≥ 6/10 on a numerical scale) in the pre-hospital setting.
Key facts
- Sponsor
- CHU De Martinique
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Population Characteristics [N01], Health Care [N] - Health Care Quality, Access, and Evaluation [N05], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
- Decision date (initial)
- 2025-11-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- GIRCI-SOHO
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Therapy
To compare the analgesic efficacy 15 minutes after intravenous injection of morphine or alfentanil in adults with severe acute pain (≥ 6/10 on a numerical scale) in the pre-hospital setting.
Secondary objectives 8
- Compare the respiratory tolerence during pre-hospital care between the 2 treatment groups.
- Compare the haemodynamic tolerance during pre-hospital care between the 2 treatment groups.
- Compare the neurological tolerance during pre-hospital care between the 2 treatment groups.
- Compare the digestive tolerance during pre-hospital care between the 2 treatment groups.
- Compare the cutaneous tolerance during pre-hospital care between the 2 treatment groups.
- Compare between the 2 treatment groups the need for recourse to other analgesic or sedative drugs after the first injection of the analgesic treatment under study allocated by the randomisation protocol during the emergency medical services management phase.
- Compare the duration of the pre-hospital phase between the 2 treatment groups.
- Compare, according to the type of pain (traumatic or visceral), the analgesic efficacy 15 minutes after intravenous injection of morphine or alfentanil in adults with severe acute pain (≥ 6/10 on a numerical scale) in the pre-hospital setting.
Conditions and MedDRA coding
Severe pain
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10056350 | Pain management | 100000004865 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Morphine arm Patient randomisation is carried out using randomisation envelopes. This randomisation assigns the patient a treatment number and an inclusion number at random, in ascending order of the randomisation list established by the Methodology and Data Management Centre of the Martinique University Hospital before the start of the research. This list will be established using RedCAP® software.
For each centre, the sponsor will prepare the number of envelopes corresponding to the randomisation list, which is composed of blocks of different sizes, taking into account the centre's recruitment commitment and lost to follow-up cases.
The batch of envelopes will be sent to the principal investigators at each centre. However, if patient inclusion is carried out directly by the investigator, randomisation will be carried out by the nurse from the SAMU team. She will assign the randomisation envelopes, each containing the treatment to be administered, in chronological order and in accordance with the inclusion number.
|
Randomised Controlled | Double | [{"id":156394,"code":2,"name":"Investigator"},{"id":156395,"code":1,"name":"Subject"}] | Morphine arm: Patient randomisation is carried out by the nurse from the SAMU team, using randomisation envelopes. This randomisation assigns the patient a treatment number and an inclusion number at random, in ascending order from the randomisation list established by the sponsor. Each centre receives the number of randomisation envelopes corresponding to its recruitment commitment, taking into account those lost to follow-up. Translated with DeepL.com (free version) |
| 2 | Alfentanil arm Patient randomisation is carried out using randomisation envelopes. This randomisation assigns the patient a treatment number and an inclusion number at random, in ascending order of the randomisation list established by the Methodology and Data Management Centre of the Martinique University Hospital before the start of the research. This list will be established using RedCAP® software.
For each centre, the sponsor will prepare the number of envelopes corresponding to the randomisation list, which is composed of blocks of different sizes, taking into account the centre's recruitment commitment and lost to follow-up cases.
The batch of envelopes will be sent to the principal investigators at each centre. However, if patient inclusion is carried out directly by the investigator, randomisation will be carried out by the nurse from the SAMU team. She will assign the randomisation envelopes, each containing the treatment to be administered, in chronological order and in accordance with the inclusion number.
|
Randomised Controlled | Double | [{"id":156398,"code":1,"name":"Subject"},{"id":156397,"code":2,"name":"Investigator"}] | Alfentanil arm: Patient randomisation is carried out by the nurse from the SAMU team, using randomisation envelopes. This randomisation assigns the patient a treatment number and an inclusion number at random, in ascending order from the randomisation list established by the sponsor. Each centre receives the number of randomisation envelopes corresponding to its recruitment commitment, taking into account those lost to follow-up. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients aged 18 or over
- Attended by a SMUR team participating in the study and
- Presenting with severe acute pain defined by a numerical scale that he rates as 6/10 or more
- Person affiliated to or benefiting from a social security scheme in France and
- Free informed consent from the patient (possibility of inclusion in an emergency situation and signed consent to continue in the study
Exclusion criteria 17
- Patient having already received treatment with opiates/opioids or agonist-antagonist morphinomimetics, or partial antagonists, in the 6 hours prior to the arrival of the emergency medical services
- Known history of chronic respiratory failure, end-stage renal disease, hepatocellular insufficiency or myasthenia gravis
- Pregnant or breast-feeding women (known condition)
- Inability to use a venous or intraosseous approach
- Not affiliated to a Social Security scheme (beneficiary or beneficiary's beneficiary)
- Persons taking part in other research involving a period of exclusion still in progres
- Inability to self-assess pain
- 2nd or 3rd degree burns > 10% of skin surface area
- Indication and possibility of performing a locoregional anaesthetic (e.g. iliofacial block)
- Estimated weight >120 kg
- Initial loss of consciousness defined as GCS (Glasgow Coma Scale) < 15
- Arterial hypotension defined as systolic blood pressure < 80 mmHg
- Presence of initial respiratory failure defined as respiratory rate <12 cycles per min and/or oxygen saturation <90% on room air
- Known hypersensitivity to morphine
- Head injury and intracranial hypertension in the absence of controlled ventilation
- Uncontrolled epilepsy
- Known hypersensitivity to excipients present in the composition of morphine and/or alfentanil.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of patients with a pain level ≤ 3/10 measured on a numerical scale (EN) 15 minutes after the first injection of the analgesic treatment allocated by the randomisation protocol (morphine or alfentanil).
Secondary endpoints 8
- Percentage of patients with side effects respiratory, assessed by respiratory rate < 12 cycles/min and/or oxygen saturation < 90% on room air
- Percentage of patients with side effects haemodynamic, assessed by systolic blood pressure below 80 mmHg.
- Percentage of patients with side effects neurological, assessed by WHO sedation scale > S1 (S0 awake / S1 intermittently drowsy, easily awakened / S2 drowsy most of the time, awakened by verbal stimulation / S3 drowsy most of the time, awakened by tactile stimulation) or requiring recourse to naloxone.
- Percentage of patients with side effects digestive, assessed by the presence of nausea and/or vomiting.
- Percentage of patients with side effects cutaneous, assessed by the presence of pruritus.
- Percentage of patients who received additional analgesic and/or sedative treatment during SMUR care after the first injection of morphine or alfentanil (other than paracetamol).
- Time (in minutes) between first injection of analgesic and arrival at hospital.
- Percentage of patients, according to pain type (traumatic or visceral), with a pain level ≤ 3/10 measured using a numerical scale (NS) 15 minutes after the first injection of the analgesic treatment assigned by the randomisation protocol (morphine or alfentanil).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
RAPIFEN 1 mg (0,5 mg/ml), solution injectable
PRD7253935 · Product
- Active substance
- Alfentanil Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 1.2 mg/kg milligram(s)/kilogram
- Max total dose
- 1.8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH02 — ALFENTANIL
- Marketing authorisation
- 34009 554 605 7 2
- MA holder
- PIRAMAL CRITICAL CARE B.V.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- In this trial, ALFENATANIL is used to treat acute pain in pre-hospital care in consenting adults but not as anaesthesia according to it marketing authorisation
Comparator 1
MORPHINE (CHLORHYDRATE) AGUETTANT 10 mg/mL, solution injectable
PRD586318 · Product
- Active substance
- Morphine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 12 mg/kg milligram(s)/kilogram
- Max total dose
- 18 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA01 — MORPHINE
- Marketing authorisation
- 34009 369 106 8 3
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHU De Martinique
- Sponsor organisation
- CHU De Martinique
- Address
- P. O. Box 90632
- City
- Fort De France Cedex
- Postcode
- 97261
- Country
- France
Scientific contact point
- Organisation
- CHU De Martinique
- Contact name
- Principal Investigator
Public contact point
- Organisation
- CHU De Martinique
- Contact name
- Clinical Research and Innovation office
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 242 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Martinique
Service d’Accueil des Urgences Adultes -SAMU 972, P. O. Box 90632, 97261, Fort De France Cedex
Centre Hospitalier De Cayenne
Service d’Accueil des Urgences – SAMU/SMUR, Avenue Des Flamboyants, 97300, Cayenne
Centre Hospitalier Universitaire De Poitiers
Service des urgences adultes SAMU-SMUR, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De La Guadeloupe
Service du SAMU-SMUR, Route De Chauvel, 97139, Les Abymes
Centre Hospitalier Universitaire De Toulouse
Service d’Aide Médicale d’Urgence de la Haute-Garonne, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2025-522817-50-00 | 6.0 |
| Recruitment arrangements (for publication) | K1_ Informed consent_ Patient recruitment procedure | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and continued CF adults | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF LAR | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC morphine | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Rapifen | 1.0 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ ENG 2025-522817-50-00 | 5.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-08 | France | Acceptable 2025-11-20
|
2025-11-24 |