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

NCT02914678 | Completed

• 1 other identifier: AU-PHA2V3
• Study Type: interventional
• Target: 7,093
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Pain

Keywords

Emergency Medical Services; Analgesics

Outcome Measures

Primary Outcomes (1)

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

  Up to 6 hours

Secondary Outcomes (4)

• Proportion of patients with reduced Glasgow Coma Scale (<15) after fentanyl administration and at any given point during transport

  Up to 6 hours

• Proportion of patients with reduced respiratory rate (<10/minute) after fentanyl administration and at any given point during transport

  Up to 6 hours

• Proportion of patients with reduced peripheral oxygen saturation (< 90%) after fentanyl administration and at any given point during transport

  Up to 6 hours

• Proportion of patients with hypotension after fentanyl administration and at any given point during transport

  Up to 6 hours

Study Arms (2)

Existing treatment

NO INTERVENTION

Business as usual: Ambulance personnel use existing treatment approach (a total of 2 μg/kg fentanyl per transport)

More liberal treatment

EXPERIMENTAL

Ambulance personnel use a more liberal treatment approach (a total of 3 μg/kg fentanyl per transport)

Other: Fentanyl

Interventions

Fentanyl OTHER

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

More liberal treatment

Eligibility Criteria

• Age: Up to 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Related Publications (4)

• 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.

  PMID: 26612100 BACKGROUND

• 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.

  PMID: 21775347 BACKGROUND

• 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.

  PMID: 24965263 BACKGROUND

• 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.

  PMID: 30732618 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kristian Friesgaard, MD, PhD Student

  University of Aarhus

  PRINCIPAL INVESTIGATOR

• Lone Nikolajsen, DmSc

  Aarhus University Hospital

  STUDY CHAIR

• Hans Kirkegaard, Professor

  Aarhus University Hospital

  STUDY CHAIR

• Erika Frischknecht Christensen, Professor

  North Denmark Region

  STUDY CHAIR

• Matthias Giebner, MD

  Central Denmark Region

  STUDY CHAIR

• Claus-Henrik Rasmussen, MD

  Central Denmark Region

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 26, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share