Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures

NCT03702023 | Unknown Phase 4 FDA Drug

• 1 other identifier: Acetaminophen in EP procedures
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Electrophysiology Procedure Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Placebo Oral Tablet

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Acetaminophen DRUG

Intervention group will receive 1000 mg of acetaminophen

Also known as: Tylenol

Intervention Group

Placebo Oral Tablet DRUG

Control group will be given a placebo capsule.

Also known as: Placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Over 18
• Weight: Greater than 50kg
• Scheduled for an EP procedure
• Be able to take oral medications
• Provide signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ascension Health: lead

Study Sites (1)

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

Location

Related Publications (4)

• 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.

  PMID: 24682348 BACKGROUND

• 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.

  PMID: 25488958 BACKGROUND

• 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.

  PMID: 21353105 BACKGROUND

• 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.

  PMID: 26157186 BACKGROUND

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michael Taipale, D.O.

  Ascension Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Fellow

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: October 10, 2018
• Study Start: February 8, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)