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Platelet Reactivity With Fentanyl, Morphine, or no Narcotic

Sponsor
Spectrum Health - Lakeland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05367336
Collaborator
(none)
100
Enrollment
3
Arms
11.8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal is to determine whether fentanyl and morphine have similar effects in reducing aspirin's effect upon platelets in emergency department patients with chest discomfort. Morphine has been shown to worsen outcomes in heart attack patients due to reduction of oral anti-platelet agent effectiveness and so many providers have switches to using fentanyl. However, it is largely unknown whether fentanyl has similar effects.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Detailed Description

Patients presenting to the emergency department with chest discomfort who are being administered aspirin will be offered enrollment in this study. At the time of their zero and two hour troponin we will also draw platelet aggregration studies to determine the effects of aspirin upon platelets. Narcotic medicines slow the absorption of aspirin. Morphine has therefore been shown to decrease the effectiveness of aspirin. Many providers therefore use fentanyl instead, however little is known about the effects of fentanyl upon aspirin. We will therefore compare the platelet reactivity of patients receiving morphine, fentanyl, or no narcotics

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Comparison of PLAtelet Response to Aspirin Between Emergency Department Patients With Chest Pain Receiving Fentanyl or Morphine (PLAAFM)
Anticipated Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

not receiving any narcotics
Experimental: Morphine

the second group will be those receiving morphine

Drug: Morphine
second group will be receiving morphine
Experimental: Fentanyl

the 3rd group will be those receiving fentanyl

Drug: Fentanyl
third group receiving fentanyl

Outcome Measures

Primary Outcome Measures

  1. platelet aggregation [2 hours]

    arachidonic acid platelet aggregation activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Adult Emergency Department patients undergoing 0 and 2 hour troponin testing

  • administered aspirin within 30 minutes of the initial blood draw.

  • patient presented via private vehicle

  • provide informed consent

Exclusion Criteria:

  • Patients not expected to get a 2 hour troponin;

  • patients already on aspirin, clopidogrel, or stronger anti-coagulants;

  • patients who arrived via EMS (Emergency Medical Services) given it can be difficult to find the run reports to determine whether patient received fentanyl in the pre-hospital period;

  • pregnant patients;

  • patients on chronic narcotics;

  • patients already once enrolled in this study,

  • inability to provide consent in English

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Spectrum Health - Lakeland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Spectrum Health - Lakeland
ClinicalTrials.gov Identifier:
NCT05367336
Other Study ID Numbers:
  • EGME#04-2021
First Posted:
May 10, 2022
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Fentanyl
Morphine

Study Results

No Results Posted as of May 10, 2022