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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
194
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
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
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
Efficiency of Analgesia
Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.
Time frame: 30 minutes
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.
Time frame: 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.
Time frame: Every 10 minutes
Patient Satisfaction
Time frame: 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
Time frame: Every 10 minutes
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