Sufentanil Intranasal | NCT04137198

Studies
Sufentanil Intranasal

NCT04137198

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Status

Unknown status

Last Update Posted

Feb 5, 2021Actual

Enrollment

170Estimated

Phase

Phase 4

Conditions

Emergencies
Pain, Acute
Analgesia
Sufentanil

Interventions

Sufentanil

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2020Actual

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Sep 1, 2025Estimated

First Submitted Date

Oct 22, 2019

First Submission Date that Met QC Criteria

Oct 22, 2019

First Posted Date

Oct 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2021

Last Update Posted Date

Feb 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	No Intervention	classic analgetic protocol
intervention	Experimental	intranasal Sufentanil	Drug: Sufentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sufentanil	Drug	intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses	intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	15-20 minutes after first administration of Sufentanil

Secondary Outcomes

Measure	Description	Time Frame
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)	60 minutes after first administration of Sufentanil

Other Outcomes

Measure	Description	Time Frame
number of participants with adverse effects	subjects are questioned and examined for known adverse effects of Sufentanil	at 15-20 and at 60 minutes

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bernard Kreps, MD	Contact	+3225353495		bernard_kreps@stpierre-bru.be
Stefano Malinverni, MD	Contact			stefano_malinverni@stpierre-bru.be

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint Pierre	Recruiting	Brussels		1000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37770120	Derived	Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.

Type	Date	Date Unknown
Release	Mar 29, 2023
Reset	Jan 5, 2024

ID	Term
D004630	Emergencies
D059787	Acute Pain
D000377	Agnosia
D010146	Pain

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

ID	Term
D005283	Fentanyl
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds