Acute PainSUURGENCT05498831
Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room.
An observational study of Acute Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse
- How many people
- 245 participants
- Where
- 1 siteFrance
- Study dates
- 9 Aug 2022to 23 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.
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.
Read the detailed description
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.
- Conditions
- Acute Pain
- Being tested
- Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse
- Keywords
- sufentanil, emergencies
- Medical subject headings
- Acute Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurseOther
Pain will be assessed using a numerical scale
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (2)
Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration
Measured: 2 hours
Number of adverse events
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start9 Aug 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Rottner, MD, Principal investigator, Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498831
- Sponsor's protocol ID
- GHR 1260
- Acronym
- SUURGE
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2022
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Pain Management Protocol Involving Intranasal Sufentanil in the Emergency Room : a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05498831
- Acronym / sponsor ID
- SUURGE / GHR 1260
- Conditions
- Acute Pain
- Keywords
- sufentanil, emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain relief protocol according to the recommendations of the French Emergency Medicine Society | – | Other: Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurseThe 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. |
| Pain relief protocol with intranasal sufentanil as a starter | – | Other: Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nurseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Mulhouse emergency department with pain greater than or equal to 4 on the Numerical Scale
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain assessment at 15 minutes, 30 minutes, 60 minutes, 120 minutes after initial assessment by the triage nursePain will be assessed using a numerical scale | Other | Pain relief protocol according to the recommendations of the French Emergency Medicine Society, Pain relief protocol with intranasal sufentanil as a starter |
Primary outcome
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
2 secondary outcomes
Time from initial pain assessment by nurse to administration of intranasal sufentanil compared to Intravenous morphine titration
Time frame: 2 hours
Number of adverse events
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Rottner, MD principal investigator
Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with effective pain relief 30 minutes after initial assessment by nurse (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.