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Sufentanil Intranasal

C

Centre Hospitalier Universitaire Saint Pierre

Status and phase

Enrolling
Phase 4

Conditions

Sufentanil
Emergencies
Pain, Acute
Analgesia

Treatments

Drug: Sufentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT04137198
SUFIN002

Details and patient eligibility

About

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

Full 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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 2 patient groups

control
No Intervention group
Description:
classic analgetic protocol
intervention
Experimental group
Description:
intranasal Sufentanil
Treatment:
Drug: Sufentanil

Trial contacts and locations

1

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Central trial contact

Stefano Malinverni, MD; Bernard Kreps, MD

Data sourced from clinicaltrials.gov

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