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

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ClinicalTrials.gov Identifier: NCT02914678
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Pain Other: Fentanyl Not Applicable

Detailed Description:

A prospective cluster-randomized trial observing proportional differences in sufficient pain relief at hospital admission (NRS < 4) and potential fentanyl related side-effects between patients treated by ambulance personnel applying either:

  • a more liberal treatment approach (a total of 3 μg/kg per transport) or
  • existing treatment approach (a total of 2 μg/kg per transport).

The Ambulance stations and their affiliated ambulance personnel are stratified into 5 clusters according to size/average transports per month and randomized to either liberal or existing treatment approach within each cluster. As patients are not randomized on an individual level baseline differences between the two groups and its patients are adjusted statistically with relevant confounders on 3 overall levels:

  1. Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
  2. Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
  3. Ambulance stations and geographical factors: prehospital time measures and geographical distance from site of emergency to hospital.

These covariates are obtained from the Danish National Patient Registry, the Danish Civil Registration System and the electronic prehospital patient journal.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7093 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting: A Prospective Cluster-randomized Comparison of 2 vs. 3 μg/kg/Transport
Actual Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Existing treatment
Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport)
Experimental: More liberal treatment
Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport)
Other: Fentanyl
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport




Primary Outcome Measures :
  1. Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival [ Time Frame: Up to 6 hours ]

Secondary Outcome Measures :
  1. Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport [ Time Frame: Up to 6 hours ]
  2. Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport [ Time Frame: Up to 6 hours ]
  3. Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport [ Time Frame: Up to 6 hours ]
  4. Proportion of patients with hypotension after fentanyl administration and at any given point during transport [ Time Frame: Up to 6 hours ]
    Hypotension defined as a drop in mean arterial pressure (MAP) >= 10 mmHg to a MAP < 70 mmHg



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Ages Eligible for Study:   up to 110 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with acute pain treated with intravenous fentanyl by ambulance personnel

Exclusion Criteria:

  • Reduced conscious level (GCS < 15) before initiation of fentanyl treatment
  • Reduced respiratory rate (< 10/minute) before initiation of fentanyl treatment
  • Patient weight < 30 kg
  • Known opioid allergy
  • Women in labour
  • Chronic pain conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914678


Sponsors and Collaborators
University of Aarhus
Central Denmark Region
Investigators
Principal Investigator: Kristian Friesgaard, MD, PhD Student University of Aarhus
Study Chair: Lone Nikolajsen, DmSc Aarhus University Hospital
Study Chair: Hans Kirkegaard, Professor Aarhus University Hospital
Study Chair: Erika Frischknecht Christensen, Professor Northern Denmark Region
Study Chair: Matthias Giebner, MD Central Denmark Region
Study Chair: Claus-Henrik Rasmussen, MD Central Denmark Region

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02914678     History of Changes
Other Study ID Numbers: AU-PHA2V3
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus:
Emergency Medical Services
Analgesics

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics