Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

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ClinicalTrials.gov Identifier: NCT03702023

Recruitment Status : Enrolling by invitation

First Posted : October 10, 2018

Last Update Posted : July 2, 2019

Sponsor:

Information provided by (Responsible Party):

Andrew Hinojos, Ascension Genesys Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post Electrophysiology Procedure Pain	Drug: Acetaminophen Drug: Placebo Oral Tablet	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
Actual Study Start Date :	February 8, 2019
Estimated Primary Completion Date :	June 1, 2020
Estimated Study Completion Date :	June 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Acetaminophen

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Placebo

Outcome Measures

Primary Outcome Measures :

Numerical rating scale measurement of pain in response to electrophysiology procedures and change in pain over time. [ Time Frame: 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 :

Additional Pain Medication [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702023

Locations

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

Sponsors and Collaborators

Ascension Genesys Hospital

Investigators

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

More Information

Publications:

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. 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.

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. Review.

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Responsible Party:	Andrew Hinojos, Cardiology Fellow, Ascension Genesys Hospital
ClinicalTrials.gov Identifier:	NCT03702023 History of Changes
Other Study ID Numbers:	Acetaminophen in EP procedures
First Posted:	October 10, 2018 Key Record Dates
Last Update Posted:	July 2, 2019
Last Verified:	June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	No plans at this time to share IPD with other researchers

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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

Additional relevant MeSH terms:

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Acetaminophen Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics

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