Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

Ascension Health

Status and phase: Unknown; Phase 4

Conditions: Post Electrophysiology Procedure Pain

Treatments: Drug: Placebo Oral Tablet; Drug: Acetaminophen

Study type: Interventional

Funder types: Industry

Identifiers

NCT03702023

Acetaminophen in EP procedures

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Intervention Group

Active Comparator group

Description:

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

Treatment:

Drug: Acetaminophen

Placebo Oral Tablet

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet