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Completed

NCT Number: NCT02914678

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

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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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:

  • Patients: Charlson Comorbidity Index Score, main overall diagnose category, inhospital surrogate measures of disease severity (intensive care unit admission and 30-day mortality).
  • Ambulance personnel: Years of experience and preinterventional cumulative fentanyl administration and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Other

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

Primary outcomes

  1. Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival

    Time frame: Up to 6 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2016
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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