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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7093 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
- Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival [ Time Frame: Up to 6 hours ]
- 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 ]
- 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 ]
- 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 ]
- 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
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
|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|