Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03702023|
Recruitment Status : Enrolling by invitation
First Posted : October 10, 2018
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post Electrophysiology Procedure Pain||Drug: Acetaminophen Drug: Placebo Oral Tablet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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 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
- 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.
- 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.
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
|United States, Michigan|
|Ascension Genesys Hospital|
|Grand Blanc, Michigan, United States, 48439|
|Principal Investigator:||Michael Taipale, D.O.||Ascension Genesys Hospital|