Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain focused on measuring Emergency Medical Services, Analgesics
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Existing treatment
More liberal treatment
Arm Description
Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport)
Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport)
Outcomes
Primary Outcome Measures
Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival
Secondary Outcome Measures
Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport
Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport
Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport
Proportion of patients with hypotension after fentanyl administration and at any given point during transport
Hypotension defined as a drop in mean arterial pressure (MAP) >= 10 mmHg to a MAP < 70 mmHg
Full Information
NCT ID
NCT02914678
First Posted
September 12, 2016
Last Updated
October 25, 2017
Sponsor
University of Aarhus
Collaborators
Central Denmark Region
1. Study Identification
Unique Protocol Identification Number
NCT02914678
Brief Title
Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Central Denmark Region
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Emergency Medical Services, Analgesics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7093 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Existing treatment
Arm Type
No Intervention
Arm Description
Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport)
Arm Title
More liberal treatment
Arm Type
Experimental
Arm Description
Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport)
Intervention Type
Other
Intervention Name(s)
Fentanyl
Intervention Description
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
Primary Outcome Measure Information:
Title
Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival
Time Frame
Up to 6 hours
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Proportion of patients with hypotension after fentanyl administration and at any given point during transport
Description
Hypotension defined as a drop in mean arterial pressure (MAP) >= 10 mmHg to a MAP < 70 mmHg
Time Frame
Up to 6 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristian Friesgaard, MD, PhD Student
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lone Nikolajsen, DmSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hans Kirkegaard, Professor
Organizational Affiliation
Aarhus University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Erika Frischknecht Christensen, Professor
Organizational Affiliation
Northern Denmark Region
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Matthias Giebner, MD
Organizational Affiliation
Central Denmark Region
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claus-Henrik Rasmussen, MD
Organizational Affiliation
Central Denmark Region
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26612100
Citation
Friesgaard KD, Nikolajsen L, Giebner M, Rasmussen CH, Riddervold IS, Kirkegaard H, Christensen EF. Efficacy and safety of intravenous fentanyl administered by ambulance personnel. Acta Anaesthesiol Scand. 2016 Apr;60(4):537-43. doi: 10.1111/aas.12662. Epub 2015 Nov 27.
Results Reference
background
PubMed Identifier
21775347
Citation
Lynge E, Sandegaard JL, Rebolj M. The Danish National Patient Register. Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.
Results Reference
background
PubMed Identifier
24965263
Citation
Schmidt M, Pedersen L, Sorensen HT. The Danish Civil Registration System as a tool in epidemiology. Eur J Epidemiol. 2014 Aug;29(8):541-9. doi: 10.1007/s10654-014-9930-3. Epub 2014 Jun 26.
Results Reference
background
PubMed Identifier
30732618
Citation
Friesgaard KD, Kirkegaard H, Rasmussen CH, Giebner M, Christensen EF, Nikolajsen L. Prehospital intravenous fentanyl administered by ambulance personnel: a cluster-randomised comparison of two treatment protocols. Scand J Trauma Resusc Emerg Med. 2019 Feb 7;27(1):11. doi: 10.1186/s13049-019-0588-4.
Results Reference
derived
Learn more about this trial
Is There an Ideal Dose of Intravenous Fentanyl in the Prehospital Setting
We'll reach out to this number within 24 hrs