Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
ALGOFINE-2
1 other identifier
interventional
194
1 country
6
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2013
Typical duration for phase_4
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2013
CompletedFirst Submitted
Initial submission to the registry
February 11, 2014
CompletedFirst Posted
Study publicly available on registry
March 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedAugust 13, 2025
December 1, 2017
2.7 years
February 11, 2014
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficiency of Analgesia
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.
30 minutes
Secondary Outcomes (4)
Opioid-related side effects
10 minutes
Efficiency of Analgesia
Every 10 minutes
Patient Satisfaction
40 min
Specific Analysis for the pre hospital setting group: Efficiency of Analgesia
Every 10 minutes
Study Arms (2)
IN Sufentanil AND IV Placebo
EXPERIMENTALPatient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration
IV Morphine AND IN Placebo
ACTIVE COMPARATORPatient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- Traumatic pain
- Numeric Pain Rating Scale (NPRS) \>5 /10
- Age between 18 and 75 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- Fondation Apicilcollaborator
- SFMUcollaborator
Study Sites (6)
Emergency Department - Hospital Albertville
Albertville, France
Emergency Department - Hospital Annecy
Annecy, France
Emergency Department - Hospital Chambéry
Chambéry, France
Emergency Department - University Hospital of Grenoble
Grenoble, France
Emergency Department - Hospital Saint Jean de Maurienne
Saint-Jean-de-Maurienne, France
Emergency Department - Hospital Voiron
Voiron, France
Related Publications (1)
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.
PMID: 31310600RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Delegation de la recherche clinique et de l'innovation
Study Record Dates
First Submitted
February 11, 2014
First Posted
March 24, 2014
Study Start
August 2, 2013
Primary Completion
April 10, 2016
Study Completion
June 30, 2016
Last Updated
August 13, 2025
Record last verified: 2017-12