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

NCT05498831 | Completed

• 1 other identifier: GHR 1260
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

sufentanil; emergencies

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse

  Pain relief will be defined as numeric pain rating scale ≤ 3

  30 minutes

Secondary Outcomes (2)

• Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration

  2 hours

• Number of adverse events

  2 hours

Study Arms (2)

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.

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

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.

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

Interventions

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

Pain will be assessed using a numerical scale

Pain relief protocol according to the recommendations of the French Emergency Medicine Society; Pain relief protocol with intranasal sufentanil as a starter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

Hôpital Emile Muller (GHRMSA)

Mulhouse, 68100, France

Location

MeSH Terms

Conditions

Acute Pain; Emergencies

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Guillaume Rottner, MD

  Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: August 9, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)