NCT05498831

Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room.

Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 245 (actual)
• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Until now, the Mulhouse emergency department used a protocol for severe pain based on morphine titration. In order to relieve patients' pain more quickly, a new protocol was implemented based on the use of intranasal sufentanil. The primary objective of the study is to prospectively assess the efficacy of the new pain management protocol implemented in the emergency department and based on intranasal sufentanil in combination with paracetamol and codeine for pain of moderate intensity and intranasal sufentanil in combination with paracetamol followed by morphine titration for severe pain. This new pain management protocol has been updated as part of the upcoming French High Authority for Health hospital certification, for which pain management is one of the priority criteria. This research does not change the routine care given to the patient.

Detailed description

Secondary objectives: 1. To assess the rapidity of pain relief with intranasal sufentanil compared to intravenous morphine titration 2. To compare the evolution over time of the pain with the old and new pain management protocol. 3. To assess the safety of sufentanil and morphine titration Conduct of research: When a patient is admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale, the triage nurse or doctor checks the eligibility criteria. If eligible, the nurse or doctor ensures that the patient does not object to the reuse of their data for this research. An information letter is also given to the patient. Pain will be measured by numerical rating scale at initial assessment by the triage nurse (baseline), at 15mins, 30mins, 60mins and 2hours.

Conditions

• Acute Pain

Interventions

Type	Name	Description
OTHER	Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse	Pain will be assessed using a numerical scale

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2022-08-12
• Last updated: 2023-10-30

Locations

1 site across 1 country: France