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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

Tracking Information
First Submitted Date  ICMJE August 23, 2018
First Posted Date  ICMJE October 10, 2018
Last Update Posted Date July 2, 2019
Actual Study Start Date  ICMJE February 8, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03702023 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
Official Title  ICMJE Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Post Electrophysiology Procedure Pain
Intervention  ICMJE
  • Drug: Acetaminophen
    Intervention group will receive 1000 mg of acetaminophen
    Other Name: Tylenol
  • Drug: Placebo Oral Tablet
    Control group will be given a placebo capsule.
    Other Name: Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Acetaminophen
  • Placebo Comparator: Placebo Oral Tablet
    Patients in the control group will receive a placebo orally one time prior to their scheduled electrophysiology procedure.
    Intervention: Drug: Placebo Oral Tablet
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702023
Other Study ID Numbers  ICMJE Acetaminophen in EP procedures
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plans at this time to share IPD with other researchers
Responsible Party Andrew Hinojos, Ascension Genesys Hospital
Study Sponsor  ICMJE Ascension Genesys Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Taipale, D.O. Ascension Genesys Hospital
PRS Account Ascension Genesys Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP