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

• Status: Completed
• Trial end date: 2016-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Fondation Apicil; SFMU
• Treatments: Morphine; Pharmaceutical Solutions; Sufentanil

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