Sufentanil Intranasal

Overview

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

Full Title of Study: “The Effect of Intranasal Sufentanil on Acute Posttraumatic Pain. A Randomized Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 30, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: control
    • classic analgetic protocol
  • Experimental: intervention
    • intranasal Sufentanil

Clinical Trial Outcome Measures

Primary Measures

  • change in pain score
    • Time Frame: 15-20 minutes after first administration of Sufentanil
    • 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 Measures

  • change in pain score
    • Time Frame: 60 minutes after first administration of Sufentanil
    • 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Saint Pierre
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Bernard Kreps, MD, +3225353495, bernard_kreps@stpierre-bru.be

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