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Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

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ClinicalTrials.gov Identifier: NCT03702023
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Andrew Hinojos, Ascension Genesys Hospital

Brief Summary:
The investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control.

Condition or disease Intervention/treatment Phase
Post Electrophysiology Procedure Pain Drug: Acetaminophen Drug: Placebo Oral Tablet Phase 4

Detailed Description:
Atrial arrhythmias are very common and widespread. Recent reports suggest that 9% of patients over the age of 65 currently have atrial fibrillation. In individuals of European descent the lifetime risk of atrial fibrillation is as high as 26%. Atrial fibrillation carries significant risk of complications including: a fivefold increase in risk of stroke, a threefold risk of heart failure, a twofold risk of dementia and a twofold risk of mortality. As treatment options continue to evolve, the use of catheter ablation procedures are becoming increasingly common within the United States. Currently, ablation has a class 1A recommendation for patients with symptomatic paroxysmal atrial fibrillation refractory or intolerant to at least one class I or class III antiarrhythmic medication and a class 2B indication before initiation of antiarrhythmic drug therapy. One of the known complications of catheter ablation procedures is pain following the procedure. Severe pain has been reported in up to 55% of patients undergoing ablation procedures. IV acetaminophen has been proven to be effective at controlling pain in post intra-abdominal surgery, however, its use is limited due to the cost of this medication. Other studies have suggested that there is no clear indication for IV over oral acetaminophen in patients who are able to take oral. Empirically the investigators have seen patients complaining of pain after all electrophysiology procedures, not limited to just ablation procedures. To the best of the knowledge of the investigational team, at this time, no studies have looked at using oral pre-procedural acetaminophen to assist with pain control following electrophysiology procedures. The investigators are looking to perform a randomized, double blind, placebo controlled study to evaluate the use of pre-procedural oral acetaminophen to help control post procedural pain.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
Actual Study Start Date : February 8, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention Group
Patients in the intervention group with receive the study medication 1000mg acetaminophen orally one time prior to their scheduled electrophysiology procedure.
Drug: Acetaminophen
Intervention group will receive 1000 mg of acetaminophen
Other Name: Tylenol

Placebo Comparator: Placebo Oral Tablet
Patients in the control group will receive a placebo orally one time prior to their scheduled electrophysiology procedure.
Drug: Placebo Oral Tablet
Control group will be given a placebo capsule.
Other Name: Placebo




Primary Outcome Measures :
  1. Numerical rating scale measurement of pain in response to electrophysiology procedures and change in pain over time. [ Time Frame: 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. ]
    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.


Secondary Outcome Measures :
  1. Additional Pain Medication [ Time Frame: We will monitor the patients for additional doses of pain medication from the time their procedure is completed and the following 24 hours. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03702023


Locations
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United States, Michigan
Ascension Genesys Hospital
Grand Blanc, Michigan, United States, 48439
Sponsors and Collaborators
Ascension Genesys Hospital
Investigators
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Principal Investigator: Michael Taipale, D.O. Ascension Genesys Hospital

Publications:
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Responsible Party: Andrew Hinojos, Cardiology Fellow, Ascension Genesys Hospital
ClinicalTrials.gov Identifier: NCT03702023     History of Changes
Other Study ID Numbers: Acetaminophen in EP procedures
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans at this time to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics