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Sufentanil Intranasal

Primary Purpose

Emergencies, Pain, Acute, Analgesia

Status

Recruiting

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Sufentanil

About this trial

This is an interventional treatment trial for Emergencies focused on measuring emergency, pain, analgesia, intranasal, sufentanil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more

Exclusion Criteria:

pregnant
<18 years
prisoners
lesions of head, face or abdomen
no consent given or possible
pain not scorable
known drug abuse or substitution therapy
chronic level 3 pain medication
intake of level 3 < 8 hours
intoxicated patient
allergy or intolerance to opiates
renal or hepatic insufficiency
< 50kg body weight
hemodynamic instability

Sites / Locations

CHU Saint PierreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

intervention

Arm Description

classic analgetic protocol

intranasal Sufentanil

Outcomes

Primary Outcome Measures

change in pain score

pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)

Secondary Outcome Measures

change in pain score

pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)

Full Information

NCT ID

NCT04137198

First Posted

October 22, 2019

Last Updated

February 4, 2021

Sponsor

Centre Hospitalier Universitaire Saint Pierre

1. Study Identification

Unique Protocol Identification Number

NCT04137198

Brief Title

Sufentanil Intranasal

Official Title

The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 22, 2020 (Actual)

Primary Completion Date

July 30, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

Detailed Description

In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm. The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil. Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.

6. Conditions and Keywords

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

Emergencies, Pain, Acute, Analgesia, Sufentanil

Keywords

emergency, pain, analgesia, intranasal, sufentanil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

randomized trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

classic analgetic protocol

Arm Title

intervention

Arm Type

Experimental

Arm Description

intranasal Sufentanil

Intervention Type

Drug

Intervention Name(s)

Sufentanil

Other Intervention Name(s)

Sufenta Forte

Intervention Description

intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses

Primary Outcome Measure Information:

Title

change in pain score

Description

pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)

Time Frame

15-20 minutes after first administration of Sufentanil

Secondary Outcome Measure Information:

Title

change in pain score

Description

pain score is measured using an analogue visual pain reporting scale (0-10, 0 for no pain at all and 10 for worst pain imaginable)

Time Frame

60 minutes after first administration of Sufentanil

Other Pre-specified Outcome Measures:

Title

number of participants with adverse effects

Description

subjects are questioned and examined for known adverse effects of Sufentanil

Time Frame

at 15-20 and at 60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more Exclusion Criteria: pregnant <18 years prisoners lesions of head, face or abdomen no consent given or possible pain not scorable known drug abuse or substitution therapy chronic level 3 pain medication intake of level 3 < 8 hours intoxicated patient allergy or intolerance to opiates renal or hepatic insufficiency < 50kg body weight hemodynamic instability

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bernard Kreps, MD

Phone

+3225353495

bernard_kreps@stpierre-bru.be

First Name & Middle Initial & Last Name or Official Title & Degree

Stefano Malinverni, MD

stefano_malinverni@stpierre-bru.be

Facility Information:

Facility Name

CHU Saint Pierre

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stefano Malinverni, MD

Phone

+3225354051

stefano_malinverni@stpierre-bru.be

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After publication all IPD will be made available through researchgate.com profile of backup investigator

IPD Sharing Time Frame

After publication

IPD Sharing Access Criteria

access will be granted to any researcher requesting access through Researchgate.com

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Sufentanil Intranasal

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