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

Study Overview
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Brief Summary
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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.

Official Title
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Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study

Conditions
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Severe Traumatic Pain, Numeric Pain Rating Scale > 5 / 10

Intervention / Treatment
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* Drug: Morphine
* Drug: Sufentanil
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IN Sufentanil AND IV Placebo<br>Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration | Drug: Sufentanil<br>* 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<br>Drug: Placebo<br>* 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<br>* Other names: NaCl 0.9%;|
| Active Comparator: IV Morphine AND IN Placebo<br>Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray | Drug: Morphine<br>* 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<br>Drug: Placebo<br>* 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<br>* Other names: NaCl 0.9%;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate, Morphine Sulfate