Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting

PHASE4CompletedINTERVENTIONAL
Enrollment

194

Participants

Timeline

Start Date

August 2, 2013

Primary Completion Date

April 10, 2016

Study Completion Date

June 30, 2016

Conditions
Severe Traumatic PainNumeric Pain Rating Scale > 5 / 10
Interventions
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"

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"

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"

Trial Locations (6)

Unknown

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

All Listed Sponsors
collaborator

Fondation Apicil

OTHER

collaborator

SFMU

UNKNOWN

lead

University Hospital, Grenoble

OTHER

NCT02095366 - Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting | Biotech Hunter | Biotech Hunter