Post Electrophysiology Procedure PainPhase 4NCT03702023
Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
A Phase 4 study testing Acetaminophen in people with Post Electrophysiology Procedure Pain, run by Ascension Health at 1 site in United States.
Trial summary
The investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Electrophysiology Procedure Pain
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 1 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Over 18
- Weight: Greater than 50kg
- Scheduled for an EP procedure
- Be able to take oral medications
- Provide signed written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ascension Genesys Hospital
Grand Blanc, Michigan, 48439
About this study
The investigators are purposing a study to evaluate the use of acetaminophen given prior to an electrophysiology procedure and post procedural pain control.
Read the 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.
- Conditions
- Post Electrophysiology Procedure Pain
- Being tested
- Acetaminophen, Placebo Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Intervention group will receive 1000 mg of acetaminophen
Placebo Oral TabletDrug
Also called Placebo
Control group will be given a placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: We will monitor the patients for additional doses of pain medication from the time their procedure is completed and the following 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start8 Feb 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post Electrophysiology Procedure PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascension Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Andrew Hinojos, Ascension Health
- Investigators
- Michael Taipale, D.O., Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702023
- Sponsor's protocol ID
- Acetaminophen in EP procedures
- Status last verified
- Jun 2019
- First submitted
- 23 Aug 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans at this time to share IPD with other researchers
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. No abstract available.
PubMed 24682348Bode 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.
PubMed 25488958Wininger 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.
PubMed 21353105Jibril 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.
PubMed 26157186
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Acetaminophen Use for Pain Reduction in Electrophysiology Procedures
- ClinicalTrials.gov ID
- NCT03702023
- Acronym / sponsor ID
- Acetaminophen in EP procedures
- Conditions
- Post Electrophysiology Procedure Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ascension HealthIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 10 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Drug: AcetaminophenPatients in the intervention group with receive the study medication 1000mg acetaminophen orally one time prior to their scheduled electrophysiology procedure. |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletPatients in the control group will receive a placebo orally one time prior to their scheduled electrophysiology procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: Over 18
- Weight: Greater than 50kg
- Scheduled for an EP procedure
- Be able to take oral medications
- Provide signed written informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: TylenolIntervention group will receive 1000 mg of acetaminophen | Drug | Intervention Group |
| Placebo Oral TabletAlso: PlaceboControl group will be given a placebo capsule. | Drug | Placebo Oral Tablet |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 24682348January 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.
- Background: PubMed 25488958Bode 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.
- Background: PubMed 21353105Wininger 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.
- Background: PubMed 26157186Jibril 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.
- Individual participant dataSharing planned: No. No plans at this time to share IPD with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Taipale, D.O. principal investigator
Ascension Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen in people with Post Electrophysiology Procedure Pain, run by Ascension Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702023, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.