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

Acute Pain Clinical Trial

— SUURGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05498831
• Other study ID #: GHR 1260
• Status: Completed
• Start date: August 9, 2022
• Est. completion date: February 23, 2023

Study information

• Verified date: October 2023
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Emile Muller (GHRMSA)	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration		2 hours
Secondary	Number of adverse events		2 hours