Intra Nasal Sufentanil Versus Intravenous Morphine for Acute Severe Traumatic Pain Analgesia in Emergency Setting (ALGOFINE-2)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 4

Conditions: Severe Traumatic Pain; Numeric Pain Rating Scale > 5 / 10

Treatments: Drug: Placebo; Drug: Morphine; Drug: Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02095366

ALGOFINE-2

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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194 participants in 2 patient groups

IN Sufentanil AND IV Placebo

Experimental group

Description:

Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration

Treatment:

Drug: Sufentanil

Drug: Placebo

Drug: Placebo

IV Morphine AND IN Placebo

Active Comparator group

Description:

Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray

Treatment:

Drug: Morphine

Drug: Placebo

Drug: Placebo