Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

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

Study Overview

• Status: Unknown
• Conditions: Post Electrophysiology Procedure Pain
• Intervention / Treatment: Drug: Acetaminophen; Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Ascension Genesys Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical rating scale measurement of pain in response to electrophysiology procedures and change in pain over time.	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Pain Medication	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.	We will monitor the patients for additional doses of pain medication from the time their procedure is completed and the following 24 hours.

Collaborators and Investigators

• Sponsor: Ascension Genesys Hospital
• Investigators: Principal Investigator: Michael Taipale, D.O., Ascension Genesys Hospital

Publications and helpful links

General Publications

• Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
• Jibril F, Sharaby S, Mohamed A, Wilby KJ. Intravenous versus Oral Acetaminophen for Pain: Systematic Review of Current Evidence to Support Clinical Decision-Making. Can J Hosp Pharm. 2015 May-Jun;68(3):238-47. doi: 10.4212/cjhp.v68i3.1458.
• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):2071-104. doi: 10.1161/CIR.0000000000000040. Epub 2014 Mar 28. No abstract available. Erratum In: Circulation. 2014 Dec 2;130(23):e270-1.
• Bode K, Breithardt OA, Kreuzhuber M, Mende M, Sommer P, Richter S, Doering M, Dinov B, Rolf S, Arya A, Dagres N, Hindricks G, Bollmann A. Patient discomfort following catheter ablation and rhythm device surgery. Europace. 2015 Jul;17(7):1129-35. doi: 10.1093/europace/euu325. Epub 2014 Dec 8.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 28, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: Acetaminophen in EP procedures

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans at this time to share IPD with other researchers

Drug and device information, study documents

• 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