NCT03702023

Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ascension Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Post Electrophysiology Procedure Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen	Intervention group will receive 1000 mg of acetaminophen
DRUG	Placebo Oral Tablet	Control group will be given a placebo capsule.

Timeline

• Start date: 2019-02-08
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2018-10-10
• Last updated: 2019-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study