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Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting

NCT02914678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7093

Last updated 2017-10-27

No results posted yet for this study

Summary

In a previous study the investigators evaluated the apparent efficacy and safety of intravenous fentanyl administered by ambulance personnel and found that 58.4% (CI 56.4-60.4) out of 2348 prehospital patients treated with fentanyl still experienced moderate to severe pain \[numeric rating scale (NRS, 0-10) \> 3\] at hospital arrival. The number of patients with possible fentanyl-related side effects was low.

Therefore, the aim of the present study is to explore the efficacy and safety of a liberalized pain treatment protocol for ambulance personnel (a total of 3 μg/kg per transport) compared with existing restrictive protocol (a total of 2 μg/kg per transport). The investigators hypothesize that:

* A higher proportion of patients will experience sufficient pain relief at hospital admission (NRS \< 4) using the liberalized protocol and
* There will be no differences in the proportion of potential fentanyl related side-effects are observed.

Conditions

  • Acute Pain

Interventions

OTHER

Fentanyl

Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport

Sponsors & Collaborators

  • Central Denmark Region

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kristian Friesgaard, MD, PhD Student · University of Aarhus

  • Lone Nikolajsen, DmSc · Aarhus University Hospital

  • Hans Kirkegaard, Professor · Aarhus University Hospital

  • Erika Frischknecht Christensen, Professor · North Denmark Region

  • Matthias Giebner, MD · Central Denmark Region

  • Claus-Henrik Rasmussen, MD · Central Denmark Region

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-10-31
Completion
2017-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914678 on ClinicalTrials.gov