alfentanil hydrochloride for Severe acute pain

Stratification factors

• Centre

Inclusion criteria

• {"criterion_text":"-Patients aged 18 or over"}
• {"criterion_text":"-Attended by a SMUR team participating in the study and"}
• {"criterion_text":"-Presenting with severe acute pain defined by a numerical scale that he rates as 6/10 or more"}
• {"criterion_text":"-Person affiliated to or benefiting from a social security scheme in France and"}
• {"criterion_text":"-Free informed consent from the patient (possibility of inclusion in an emergency situation and signed consent to continue in the study"}

Exclusion criteria

• {"criterion_text":"-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"}
• {"criterion_text":"-Estimated weight >120 kg"}
• {"criterion_text":"-Initial loss of consciousness defined as GCS (Glasgow Coma Scale) < 15"}
• {"criterion_text":"-Arterial hypotension defined as systolic blood pressure < 80 mmHg"}
• {"criterion_text":"-Presence of initial respiratory failure defined as respiratory rate <12 cycles per min and/or oxygen saturation <90% on room air"}
• {"criterion_text":"-Known hypersensitivity to morphine"}
• {"criterion_text":"-Head injury and intracranial hypertension in the absence of controlled ventilation"}
• {"criterion_text":"-Uncontrolled epilepsy"}
• {"criterion_text":"-Known hypersensitivity to excipients present in the composition of morphine and/or alfentanil."}
• {"criterion_text":"-Known history of chronic respiratory failure, end-stage renal disease, hepatocellular insufficiency or myasthenia gravis"}
• {"criterion_text":"-Pregnant or breast-feeding women (known condition)"}
• {"criterion_text":"-Inability to use a venous or intraosseous approach"}
• {"criterion_text":"-Not affiliated to a Social Security scheme (beneficiary or beneficiary's beneficiary)"}
• {"criterion_text":"-Persons taking part in other research involving a period of exclusion still in progres"}
• {"criterion_text":"-Inability to self-assess pain"}
• {"criterion_text":"-2nd or 3rd degree burns > 10% of skin surface area"}
• {"criterion_text":"-Indication and possibility of performing a locoregional anaesthetic (e.g. iliofacial block)"}

Primary endpoints

• {"endpoint_text":"-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).","definition_or_measurement_approach":"Pain level measured on a numerical scale (0-10); endpoint is proportion with score ≤ 3/10 assessed 15 minutes after the first IV injection of the allocated analgesic."}

Secondary endpoints

• {"endpoint_text":"-Percentage of patients with side effects respiratory, assessed by respiratory rate < 12 cycles/min and/or oxygen saturation < 90% on room air","definition_or_measurement_approach":"Respiratory adverse events defined and assessed by respiratory rate <12 cycles/min and/or SpO2 <90% on room air."}
• {"endpoint_text":"-Percentage of patients with side effects haemodynamic, assessed by systolic blood pressure below 80 mmHg.","definition_or_measurement_approach":"Haemodynamic adverse events defined as systolic blood pressure <80 mmHg."}
• {"endpoint_text":"-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.","definition_or_measurement_approach":"Neurological adverse events assessed by WHO sedation scale > S1 or need for naloxone administration."}
• {"endpoint_text":"-Percentage of patients with side effects digestive, assessed by the presence of nausea and/or vomiting.","definition_or_measurement_approach":"Digestive adverse events assessed by presence of nausea and/or vomiting."}
• {"endpoint_text":"-Percentage of patients with side effects cutaneous, assessed by the presence of pruritus.","definition_or_measurement_approach":"Cutaneous adverse events assessed by presence of pruritus."}
• {"endpoint_text":"-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).","definition_or_measurement_approach":"Proportion of patients who received additional analgesic/sedative treatments (excluding paracetamol) during SMUR care after the first injection."}
• {"endpoint_text":"-Time (in minutes) between first injection of analgesic and arrival at hospital.","definition_or_measurement_approach":"Measured time in minutes from first analgesic injection to hospital arrival."}
• {"endpoint_text":"-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).","definition_or_measurement_approach":"Subgroup analysis by pain type (traumatic vs visceral); proportion with pain ≤3/10 at 15 minutes post-injection measured on numerical scale."}

Methods

• Recruitment by SMUR/SAMU emergency teams in the pre-hospital setting (patients attended by participating SMUR teams are screened and randomised on-scene).
• Inclusion may occur in emergency situations with the nurse from the SAMU team assigning randomisation envelopes and initial inclusion; signed informed consent to continue in the study is obtained subsequently.

France

Earliest CTIS Part Ii Submission Date

24-10-2025

Latest Decision Or Authorization Date

24-11-2025

Processing Time Days

31

Number Of Sites

5

Number Of Participants

242

Primary sponsor

Full Name

CHU De Martinique

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"GIRCI-SOHO","duties_or_roles":"Source of monetary support","organisation_type":""}