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

Condition(s) targeted: Severe Traumatic Pain; Numeric Pain Rating Scale > 5 / 10

Intervention: Morphine (Drug); Sufentanil (Drug); Placebo (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Grenoble

Overall contact:
Marc BLANCHER, MD, Email: MBlancher@chu-grenoble.fr

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Efficiency of Analgesia

Secondary outcome:

Opioid-related side effects

Efficiency of Analgesia

Patient Satisfaction

Specific Analysis for the pre hospital setting group: Efficiency of Analgesia

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Marc BLANCHER, MD, Email: MBlancher@chu-grenoble.fr

Emergency Department - Hospital Annecy, Annecy, France; Recruiting

Emergency Department - Hospital Chambéry, Chambery, France; Recruiting

Emergency Department - University Hospital of Grenoble, Grenoble, France; Recruiting

Emergency Department - Hospital Voiron, Voiron, France; Recruiting

Starting date: November 2013
Last updated: March 20, 2014