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

NCT ID: NCT05498831

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 245 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2023-02-23

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pain relief protocol according to the recommendations of the French Emergency Medicine Society

The first phase consists in collecting, over a one-month period, data concerning the analgesic management of patients based on the recommendations of the 2010 French Emergency Medicine Society, before the effective implementation of the new pain management protocol, which should be implemented between 2 to 4 months later. Adverse events and patient's satisfaction will also be collected.

Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse

Intervention Type: OTHER

Pain will be assessed using a numerical scale

Pain relief protocol with intranasal sufentanil as a starter

The second phase consists in collecting, over a one-month period, data concerning the analgesic management of patients after the implementation of the new protocol based on the use of intranasal sufentanil as a starter for pain of moderate and severe intensity. Adverse events and patient's satisfaction will also be collected during the second phase.

Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse

Intervention Type: OTHER

Pain will be assessed using a numerical scale

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient admitted to the Emergency Department of Mulhouse with a numerical pain rating scale > 3 ;
• Patient who did not receive any analgesic except paracetamol in the 4 hours prior to admission ;
• Initial pain assessment with the triage nurse ;
• Patient does not object to the collection of data for the study.

Exclusion Criteria

• Patient admitted directly to the shock room ;
• Initial pain assessment not performed in triage zone ;
• Numerical Scale > 3 not corroborated by caregiver assessment: Algoplus <2
• Onset of pain after triage nurse visit ;
• Patient with drug intoxication, altered consciousness, alcohol or drug use.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Rottner, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace

Locations

Hôpital Emile Muller (GHRMSA)

Mulhouse, , France

Countries

France

Other Identifiers

GHR 1260

Identifier Type: -

Identifier Source: org_study_id