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

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914678
• Other study ID #: AU-PHA2V3
• Status: Completed
• Phase: N/A
• First received: September 12, 2016
• Last updated: October 25, 2017
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7093
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region

References & Publications (3)

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. — View 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. — View Citation

Schmidt M, Pedersen L, Sørensen 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with sufficient pain relief (NRS < 4) at hospital arrival		Up to 6 hours
Secondary	Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport		Up to 6 hours
Secondary	Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport		Up to 6 hours
Secondary	Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport		Up to 6 hours
Secondary	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	Up to 6 hours