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

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Morphine

Sufentanil

Placebo

About this trial

This is an interventional treatment trial for Severe Traumatic Pain focused on measuring Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate, Morphine Sulfate

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Emergency Department - Hospital Albertville
Emergency Department - Hospital Annecy
Emergency Department - Hospital Chambéry
Emergency Department - University Hospital of Grenoble
Emergency Department - Hospital Saint Jean de Maurienne
Emergency Department - Hospital Voiron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IN Sufentanil AND IV Placebo

IV Morphine AND IN Placebo

Arm Description

Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration

Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray

Outcomes

Primary Outcome Measures

Efficiency of Analgesia

Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.

Secondary Outcome Measures

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.

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.

Patient Satisfaction

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

Full Information

NCT ID

NCT02095366

First Posted

February 11, 2014

Last Updated

December 12, 2017

Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil, SFMU

1. Study Identification

Unique Protocol Identification Number

NCT02095366

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

August 2, 2013 (Actual)

Primary Completion Date

April 10, 2016 (Actual)

Study Completion Date

June 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Grenoble

Collaborators

Fondation Apicil, SFMU

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Acute Pain, Traumatic Pain, Emergency setting, Prehospital setting, Analgesia, Intranasal device, Intra veinous injection, Sufentanil citrate, Morphine Sulfate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

194 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IN Sufentanil AND IV Placebo

Arm Type

Experimental

Arm Description

Patient receives silmutaneously intranasal sufentanil spray AND intraveinous placebo administration

Arm Title

IV Morphine AND IN Placebo

Arm Type

Active Comparator

Arm Description

Patient receives silmutaneously intraveinous morphine administration AND intranasal placebo spray

Intervention Type

Drug

Intervention Name(s)

Morphine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sufentanil

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

saline solution, NaCl 0.9%

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

saline solution, NaCl 0.9%

Intervention Description

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

Primary Outcome Measure Information:

Title

Efficiency of Analgesia

Description

Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 30 minutes after the first opiate administration.

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Opioid-related side effects

Description

Sedation Score, Breathing Rate, Oxygen Saturation, Arterial Blood Pressure, Heart rate, Nasal Ulceration. Proportion of patients having opioid-related side effects.

Time Frame

10 minutes

Title

Efficiency of Analgesia

Description

Patient self-assessed pain intensity using Numeric Pain Rating Scale (0 to 10). 10 minutes and 20 minutes after the first opiate administration.

Time Frame

Every 10 minutes

Title

Patient Satisfaction

Time Frame

40 min

Title

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

Description

Patient self-assessed pain intensity, using Numeric Pain Rating Scale (0 to 10) at 10, 20 and 30 min after the first opiate administration

Time Frame

Every 10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Emergency Department - Hospital Albertville

City

Albertville

Country

France

Facility Name

Emergency Department - Hospital Annecy

City

Annecy

Country

France

Facility Name

Emergency Department - Hospital Chambéry

City

Chambery

Country

France

Facility Name

Emergency Department - University Hospital of Grenoble

City

Grenoble

Country

France

Facility Name

Emergency Department - Hospital Saint Jean de Maurienne

City

Saint-Jean-de-Maurienne

Country

France

Facility Name

Emergency Department - Hospital Voiron

City

Voiron

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

31310600

Citation

Blancher M, Maignan M, Clape C, Quesada JL, Collomb-Muret R, Albasini F, Ageron FX, Fey S, Wuyts A, Banihachemi JJ, Bertrand B, Lehmann A, Bollart C, Debaty G, Briot R, Viglino D. Intranasal sufentanil versus intravenous morphine for acute severe trauma pain: A double-blind randomized non-inferiority study. PLoS Med. 2019 Jul 16;16(7):e1002849. doi: 10.1371/journal.pmed.1002849. eCollection 2019 Jul.

Results Reference

derived

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

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