Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2020-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post Electrophysiology Procedure Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention Group

Patients in the intervention group with receive the study medication 1000mg acetaminophen orally one time prior to their scheduled electrophysiology procedure.

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

Intervention group will receive 1000 mg of acetaminophen

Placebo Oral Tablet

Patients in the control group will receive a placebo orally one time prior to their scheduled electrophysiology procedure.

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Control group will be given a placebo capsule.

Interventions

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Acetaminophen

Intervention group will receive 1000 mg of acetaminophen

Intervention Type DRUG

Placebo Oral Tablet

Control group will be given a placebo capsule.

Intervention Type DRUG

Other Intervention Names

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Tylenol Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No