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

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.

Conditions

• Severe Traumatic Pain
• Numeric Pain Rating Scale > 5 / 10

Interventions

DRUG

Morphine

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

DRUG

Sufentanil

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

DRUG

Placebo

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

DRUG

Placebo

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

Sponsors & Collaborators

• Fondation Apicil

  collaborator OTHER

• SFMU

  collaborator UNKNOWN

• University Hospital, Grenoble

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-02

Primary Completion

2016-04-10

Completion

2016-06-30

Countries

• France

Study Locations