Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

Phase 4

• Conditions: Post Electrophysiology Procedure Pain
• Interventions: Drug: Placebo Oral Tablet; Drug: Acetaminophen

• Registration Number: NCT03702023
• Lead Sponsor: Ascension Health

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.

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.

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-10
• Study Start: 2019-02-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-28
• Last Update Posted: 2019-07-02
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Oral Tablet	Placebo Oral Tablet	Patients in the control group will receive a placebo orally one time prior to their scheduled electrophysiology procedure.
Intervention Group	Acetaminophen	Patients in the intervention group with receive the study medication 1000mg acetaminophen orally one time prior to their scheduled electrophysiology procedure.

Primary Outcome Measures

Name	Time	Method
Numerical rating scale measurement of pain in response to electrophysiology procedures and change in pain over time.	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

Name	Time	Method
Additional Pain Medication	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.

Trial Locations

Locations (1)

Ascension Genesys Hospital; 🇺🇸 Grand Blanc, Michigan, United States