In short
Clinical trials are investigating ALFENTANIL HYDROCHLORIDE in adults with severe acute pain before hospital care. The studies aim to compare how well it relieves pain and how quickly it works, with a focus on safety and effectiveness in real emergency settings.
Key points
- Clinical trials of ALFENTANIL HYDROCHLORIDE are focused on severe acute pain in adults before hospital care. The main study compares ALFENTANIL HYDROCHLORIDE with morphine in a Phase 3 interventional trial. Researchers want to know which treatment lowers pain faster after the first injection. The key result is the share of patients whose pain drops to 3/10 or less after 15 minutes. The trial is authorised and plans to enroll 242 people.
Trial overview
The available trial is an interventional study, which means the researchers give treatments and then measure the results. It studies ALFENTANIL HYDROCHLORIDE for severe pain in the prehospital phase, meaning care given before the patient reaches the hospital.
This study is authorised and plans to include 242 participants.
Who can participate
The trial is for adults with severe acute pain in the pre-hospital setting. In the study summary, severe acute pain means a pain score of 6/10 or higher on a numerical scale.
This focus suggests the study is meant for people who need fast pain relief before they arrive at the hospital.
Treatments being compared
The study compares ALFENTANIL HYDROCHLORIDE, listed in the trial as RAPIFEN 1 mg (0.5 mg/ml), with morphine. Both treatments are given as an intravenous bolus, which means a quick dose directly into a vein.
The trial uses randomisation, so participants are assigned by chance to one of the treatment groups. This helps make the comparison fair.
Study phase and design
This is a Phase 3 trial. Phase 3 studies usually test a treatment in a larger group of people to see how well it works in real-world care.
The brief summary says the goal is to compare the analgesic effect, which means the ability to reduce pain, 15 minutes after the first injection.
Outcomes being measured
The primary outcome is the proportion of patients whose pain becomes 3/10 or lower 15 minutes after treatment. This is important because it measures both speed and strength of pain relief.
Using a numerical pain scale helps researchers compare how much pain is left after treatment. A lower score means less pain.
What this means for patients
For patients with sudden severe pain, this trial is trying to find out whether ALFENTANIL HYDROCHLORIDE or morphine gives faster relief in the pre-hospital setting. The study may help guide emergency pain treatment choices for adults who need quick care.
Because the trial measures pain only 15 minutes after the first dose, it is focused on very rapid pain control rather than long-term treatment.