Clinical trial NCT05498831: Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room.
Official title: Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Keywords: sufentanil
emergencies
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse
timeFrame: 30 minutes
Secondary outcomes:
measure: Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration
timeFrame: 2 hours
measure: Number of adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Hôpital Emile Muller (GHRMSA)
Study officials:
affiliation: Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
name: Guillaume Rottner, MD
role: PRINCIPAL_INVESTIGATOR
References: