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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05498831
Acronym
SUURGE
Enrollment
245
Registered
2022-08-12
Start date
2022-08-09
Completion date
2023-02-23
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Keywords

sufentanil, emergencies

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.

Interventions

OTHERPain 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

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse30 minutesPain relief will be defined as numeric pain rating scale ≤ 3

Secondary

MeasureTime frame
Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration2 hours
Number of adverse events2 hours

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026