Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting (ALGOFINE-2)

August 8, 2025 updated by: AdministrateurDRC, University Hospital, Grenoble

Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study

Intranasal (IN) administration of opiates is an appealing non-invasive way of treating acute traumatic pain in prehospital and Emergency departments (ED).

The investigators hypothesize that IN administration of Sufentanil is equal as compared with Intra veinous (IV) administration of Morphine wich is widely recommended in ED.

The investigators study is a multicentric, comparative, randomized, double-blind, double-placebo study, comparing quality of analgesia in both groups 30 minutes after first administration of opiates.

The investigators also asses side effects and patient satisfaction in both groups.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Albertville, France
        • Emergency Department - Hospital Albertville
      • Annecy, France
        • Emergency Department - Hospital Annecy
      • Chambery, France
        • Emergency Department - Hospital Chambéry
      • Grenoble, France
        • Emergency Department - University Hospital of Grenoble
      • Saint-Jean-de-Maurienne, France
        • Emergency Department - Hospital Saint Jean de Maurienne
      • Voiron, France
        • Emergency Department - Hospital Voiron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Traumatic pain
  • Numeric Pain Rating Scale (NPRS) >5 /10
  • Age between 18 and 75 years old

Exclusion Criteria:

  • Medical pain (headache, chest pain,...)
  • Respiratory, renal or hepatic insufficiency
  • Drug addiction
  • Medical or Chirurgical sinus history
  • Oxygene saturation < 90%
  • Systolic blood pressure < 90mmHg
  • Head injury with a neurological Glasgow Coma Scale (GCS) < 14
  • Opioid allergy
  • Facial traumatism
  • Patient unable do understand or assessing NPRS
  • Opiates administration within 6 hours before admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IN Sufentanil AND IV Placebo
Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
Drug: Sufentanil

Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray.

Pain is controlled by:

  • at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
  • at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
  • at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
Drug: Placebo

Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.

Pain is controlled by:

  • at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
  • at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
  • at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
Other Names:
  • NaCl 0.9%
  • saline solution
Drug: Placebo

Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray.

Pain is controlled by:

  • at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
  • at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
  • at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg
Other Names:
  • NaCl 0.9%
  • saline solution
Active Comparator: IV Morphine AND IN Placebo
Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray
Drug: Placebo

Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.

Pain is controlled by:

  • at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
  • at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
  • at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
Other Names:
  • NaCl 0.9%
  • saline solution
Drug: Placebo

Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray.

Pain is controlled by:

  • at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
  • at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
  • at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg
Other Names:
  • NaCl 0.9%
  • saline solution
Drug: Morphine

Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray.

Pain is controlled by:

  • at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
  • at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
  • at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficiency of Analgesia
Time Frame: 30 minutes
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.
30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid-related side effects
Time Frame: 10 minutes

Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.

Proportion of patients having opioid-related side effects.
10 minutes
Efficiency of Analgesia
Time Frame: Every 10 minutes
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.
Every 10 minutes
Patient Satisfaction
Time Frame: 40 min
40 min
Specific Analysis for the pre hospital setting group: Efficiency of Analgesia
Time Frame: Every 10 minutes
Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration
Every 10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Apicil
SFMU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALGOFINE-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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