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

Numeric Pain Rating Scale > 5 / 10 Clinical Trial

— ALGOFINE-2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02095366
• Other study ID #: ALGOFINE-2
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2014
• Last updated: December 12, 2017
• Start date: August 2, 2013
• Est. completion date: June 30, 2016

Study information

• Verified date: December 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: June 30, 2016
• Est. primary completion date: April 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
France	Emergency Department - Hospital Albertville	Albertville
France	Emergency Department - Hospital Annecy	Annecy
France	Emergency Department - Hospital Chambéry	Chambery
France	Emergency Department - University Hospital of Grenoble	Grenoble
France	Emergency Department - Hospital Saint Jean de Maurienne	Saint-Jean-de-Maurienne
France	Emergency Department - Hospital Voiron	Voiron

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Fondation Apicil, SFMU

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of Analgesia	Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.	30 minutes
Secondary	Opioid-related side effects	Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration.; Proportion of patients having opioid-related side effects.	10 minutes
Secondary	Efficiency of Analgesia	Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.	Every 10 minutes
Secondary	Patient Satisfaction		40 min
Secondary	Specific Analysis for the pre hospital setting group: Efficiency of Analgesia	Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration	Every 10 minutes