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NCT Number: NCT05498831

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Emile Muller (GHRMSA)

Mulhouse, 68100, France

About this study

Secondary objectives:

  • To assess the rapidity of pain relief with intranasal sufentanil compared to intravenous morphine titration
  • To compare the evolution over time of the pain with the old and new pain management protocol.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 30 minutes

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

Secondary outcomes

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

    Time frame: 2 hours

  2. Number of adverse events

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Official study title

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

Acronym: SUURGE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2022
Registry last updated
Oct 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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