Severe Traumatic PainPhase 4ALGOFINE-2NCT02095366
Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
A Phase 4 study testing Morphine and Sufentanil in people with Severe Traumatic Pain and Numeric Pain Rating Scale > 5 / 10, run by University Hospital, Grenoble at 6 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Severe Traumatic Pain, Numeric Pain Rating Scale > 5 / 10
- What is being tested?
- Morphine and Sufentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 194 participants
- Where
- 6 sitesFrance
- Study dates
- 2 Aug 2013to 30 Jun 2016
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic pain
- Numeric Pain Rating Scale (NPRS) >5 /10
- Age between 18 and 75 years old
Who cannot join
- Medical pain (headache, chest pain,...)
- Respiratory, renal or hepatic insufficiency
- Drug addiction
- Medical or Chirurgical sinus history
- Oxygene saturation < 90%
- Systolic blood pressure < 90mmHg
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Emergency Department - Hospital Albertville
Albertville
Emergency Department - Hospital Annecy
Annecy
Emergency Department - Hospital Chambéry
Chambéry
Emergency Department - University Hospital of Grenoble
Grenoble
Emergency Department - Hospital Saint Jean de Maurienne
Saint-Jean-de-Maurienne
Emergency Department - Hospital Voiron
Voiron
About this study
Official title: 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.
- Being tested
- Morphine, Sufentanil, Placebo
- Keywords
- Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate, Morphine Sulfate
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
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
SufentanilDrug
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
PlaceboDrug
Also called saline solution, NaCl 0.9%
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
PlaceboDrug
Also called saline solution, NaCl 0.9%
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
| Study group | Role | What they receive |
|---|---|---|
| IN Sufentanil AND IV Placebo | Experimental | Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration Receives: Drug: Sufentanil; Drug: Placebo |
| IV Morphine AND IN Placebo | Active comparator | Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray Receives: Drug: Morphine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of Analgesia
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.
Measured: 30 minutes
Secondary outcomes (4)
Opioid-related side effects
Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.
Proportion of patients having opioid-related side effects.
Measured: 10 minutes
Efficiency of Analgesia
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.
Measured: Every 10 minutes
Patient Satisfaction
Measured: 40 min
Specific Analysis for the pre hospital setting group: Efficiency of Analgesia
Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration
Measured: Every 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study start2 Aug 2013
- Primary completion10 Apr 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Traumatic PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, SFMU
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095366
- Sponsor's protocol ID
- ALGOFINE-2
- Acronym
- ALGOFINE-2
- Status last verified
- Dec 2017
- First submitted
- 11 Feb 2014
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul.
PubMed 31310600
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study
- ClinicalTrials.gov ID
- NCT02095366
- Acronym / sponsor ID
- ALGOFINE-2 / ALGOFINE-2
- Keywords
- Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Fondation Apicil, SFMU
- Study start
- 2 Aug 2013 (actual)
- Primary completion
- 10 Apr 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 24 Mar 2014 (estimated)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IN Sufentanil AND IV Placebo | Experimental | Drug: Sufentanil, Drug: PlaceboPatient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration |
| IV Morphine AND IN Placebo | Active comparator | Drug: Morphine, Drug: PlaceboPatient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Traumatic pain
- Numeric Pain Rating Scale (NPRS) >5 /10
- Age between 18 and 75 years old
Key exclusion criteria (11 listed)
- Medical pain (headache, chest pain,...)
- Respiratory, renal or hepatic insufficiency
- Drug addiction
- Medical or Chirurgical sinus history
- Oxygene saturation < 90%
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 |
|---|---|---|
| MorphineIntravenous 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 | Drug | IV Morphine AND IN Placebo |
| SufentanilIntranasal 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 | IN Sufentanil AND IV Placebo |
| PlaceboAlso: saline solution, NaCl 0.9%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 | Drug | IN Sufentanil AND IV Placebo |
| PlaceboAlso: saline solution, NaCl 0.9%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 | Drug | IV Morphine AND IN Placebo |
Primary outcome
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.
4 secondary outcomes
Opioid-related side effects
Time frame: 10 minutes
Efficiency of Analgesia
Time frame: Every 10 minutes
Patient Satisfaction
Time frame: 40 min
Specific Analysis for the pre hospital setting group: Efficiency of Analgesia
Time frame: Every 10 minutes
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 13 Aug 2025.
- Results publication: PubMed 31310600Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Morphine and Sufentanil in people with Severe Traumatic Pain and Numeric Pain Rating Scale > 5 / 10, run by University Hospital, Grenoble at 6 sites 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 3 inclusion and 11 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 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficiency of Analgesia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095366, which also lists 1 linked publication.
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 13 Aug 2025.