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

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: Completed
• Conditions: Severe Traumatic Pain; Numeric Pain Rating Scale > 5 / 10
• Intervention / Treatment: Drug: Sufentanil; Drug: Placebo; Drug: Placebo; Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Every 10 minutes
Patient Satisfaction		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	Every 10 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Fondation Apicil; SFMU

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2013
• Primary Completion (Actual): April 10, 2016
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimated): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Analgesia; Morphine Sulfate; Acute Pain; Prehospital setting; Traumatic Pain; Emergency setting; Intranasal device; Intra veinous injection; Sufentanil citrate
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Morphine; Pharmaceutical Solutions; Sufentanil
• Other Study ID Numbers: ALGOFINE-2