Skip to content

Comparison of morphine and alfentanil in the emergency treatment of severe acute pain in the pre-hospital setting

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522817-50-00
Acronym
22_RIPH1-08
Enrollment
242
Registered
2025-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-24

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

Conditions

Severe pain

Brief summary

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).

Detailed description

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).

Interventions

DRUGsolution injectable
DRUGRAPIFEN 1 mg (0
DRUG5 mg/ml)

Sponsors

CHU De Martinique
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026