Post Electrophysiology Procedure Pain Clinical Trial
Official title:
Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
Verified date | June 2019 |
Source | Genesys Regional Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age: Over 18 - Weight: Greater than 50kg - Scheduled for an EP procedure - Be able to take oral medications - Provide signed written informed consent Exclusion Criteria: - Have chronic pain requiring the use of chronic pain medications including narcotic pain medications or chronic acetaminophen use greater than seven consecutive days prior to the procedure - Known hypersensitivity to acetaminophen - Known or suspected history of alcohol or drug abuse/dependence within the previous 2 years - Known impaired liver function - Active pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | Ascension Genesys Hospital | Grand Blanc | Michigan |
Lead Sponsor | Collaborator |
---|---|
Genesys Regional Medical Center |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical rating scale measurement of pain in response to electrophysiology procedures and change in pain over time. | A standard 0-10 numerical rating scale of pain (0=no pain, 10 = the worst possible pain) will be subjectively reported to nursing staff and recorded. | The patients pain will be recorded prior to the procedure and then every one hour post procedure for four hours. Pain will then be recorded every four hours for a total of 24 hours or patient discharge from the hospital whichever comes first. | |
Secondary | Additional Pain Medication | Duration of time from the start of the procedure until the next dose of pain medication is provided. We will be monitoring the type and dose of pain medication provided. | We will monitor the patients for additional doses of pain medication from the time their procedure is completed and the following 24 hours. |