Clinical trial NCT02095366: Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting
Official title: Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting. A Multicenter,Randomized,Controled, Comparative, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Traumatic Pain
Numeric Pain Rating Scale > 5 / 10
Keywords: Acute Pain
Traumatic Pain
Emergency setting
Prehospital setting
Analgesia
Intranasal device
Intra veinous injection
Sufentanil citrate
Morphine Sulfate
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: SFMU
First posted: 2014-03-24
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Efficiency of Analgesia
timeFrame: 30 minutes
Secondary outcomes:
measure: Opioid-related side effects
timeFrame: 10 minutes
measure: Efficiency of Analgesia
timeFrame: Every 10 minutes
measure: Patient Satisfaction
timeFrame: 40 min
measure: Specific Analysis for the pre hospital setting group: Efficiency of Analgesia
timeFrame: Every 10 minutes
Other outcomes:
Locations:
city: Albertville
country: France
facility: Emergency Department - Hospital Albertville
city: Annecy
country: France
facility: Emergency Department - Hospital Annecy
city: Chambery
country: France
facility: Emergency Department - Hospital Chambéry
city: Grenoble
country: France
facility: Emergency Department - University Hospital of Grenoble
city: Saint-Jean-de-Maurienne
country: France
facility: Emergency Department - Hospital Saint Jean de Maurienne
city: Voiron
country: France
facility: Emergency Department - Hospital Voiron
Study officials:
References:
citation: 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.