PainNCT01822821
Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
A study testing IV Acetaminophen in people with Pain, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- IV Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Males or females 18 years of age or older.
- Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.
Who cannot join
- Redo cardiac surgery.
- Combined CABG (Coronary Artery Bypass Graft)\& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
- Weight < 50 Kg or Body mass index > 38 kg/m2.
- Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
- Severe (3-4 +) Tricuspid Regurgitation.
- Recent stroke (within 6 months).
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- Severe lung disease requiring home O2 therapy.
- Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis.
- History of liver cirrhosis or active liver disease.
- Chronic pain conditions controlled by preoperative opioid administration.
- Known allergy to acetaminophen or fentanyl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
- Conditions
- Pain
- Being tested
- IV Acetaminophen, Placebo
- Keywords
- Males or females, 18 years of age or older., Non-emergency, cardiac surgery, midline sternotomy.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV AcetaminophenDrug
Also called 1000mg IV Acetaminophen
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
PlaceboDrug
Also called inactive substance
Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
| Study group | Role | What they receive |
|---|---|---|
| IV Acetaminophen | Experimental | Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. Receives: Drug: IV Acetaminophen |
| Placebo | Placebo comparator | Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Opioid Consumption
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.
Measured: End of surgery through 24 hours after surgery
Pain Intensity
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).
Measured: End of surgery through 24 hours after surgery
Secondary outcomes (8)
Postoperative Nausea and Vomiting
Incidence of any postoperative nausea and vomiting within 24 hours after surgery was collected.
Measured: End of surgery through 24 hours after surgery
Postoperative Sedation
Postoperative sedation was assessed using the Richmond Agitation Sedation Scale (RASS). It ranges from -5 to +4, where -5 indicates no response to voice or physical stimulation and +4 indicates overtly combative or violent and immediate danger to staff. Lower the value, better the sedation.
Measured: Measured at 8, 16, and 24 hours after surgery
Duration of Mechanical Ventilation (Minutes)
Evaluate whether IV acetaminophen reduced duration of Mechanical Ventilation.
Measured: End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
Intensive Care Unit (ICU) Length of Stay
Evaluate whether IV acetaminophen reduced intensive care unit (ICU) Length of Stay.
Measured: End of surgery through discharge from ICU
Hospital Length of Stay
Evaluate whether IV acetaminophen hospital length of stay
Measured: end of surgery through hospital discharge
Alanine Aminotransferase (ALT); U/L
Measured: Two days after surgery or date of death from any cause, whichever came first
Aspartate Aminotransferase (AST); U/L
Measured: Two days after surgery or date of death from any cause, whichever came first
Total Bilirubin (mg/dL)
Measured: Measured at 1 day and 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Negmeldeen Mamoun, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822821
- Sponsor's protocol ID
- 13-269
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2013
- Last updated
- 15 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT01822821
- Acronym / sponsor ID
- 13-269
- Conditions
- Pain
- Keywords
- Males or females, 18 years of age or older., Non-emergency, cardiac surgery, midline sternotomy.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Acetaminophen | Experimental | Drug: IV AcetaminophenPatients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- - Males or females 18 years of age or older.
- Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.
Key exclusion criteria (11 listed)
- Redo cardiac surgery.
- Combined CABG (Coronary Artery Bypass Graft)\& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
- Weight < 50 Kg or Body mass index > 38 kg/m2.
- Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
- Severe (3-4 +) Tricuspid Regurgitation.
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 |
|---|---|---|
| IV AcetaminophenAlso: 1000mg IV AcetaminophenPatients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. | Drug | IV Acetaminophen |
| PlaceboAlso: inactive substancePatients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids. | Drug | Placebo |
Primary outcome
Cumulative Opioid Consumption
Time frame: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.
Pain Intensity
Time frame: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).
8 secondary outcomes
Postoperative Nausea and Vomiting
Time frame: End of surgery through 24 hours after surgery
Postoperative Sedation
Time frame: Measured at 8, 16, and 24 hours after surgery
Duration of Mechanical Ventilation (Minutes)
Time frame: End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
Intensive Care Unit (ICU) Length of Stay
Time frame: End of surgery through discharge from ICU
Hospital Length of Stay
Time frame: end of surgery through hospital discharge
Alanine Aminotransferase (ALT); U/L
Time frame: Two days after surgery or date of death from any cause, whichever came first
Aspartate Aminotransferase (AST); U/L
Time frame: Two days after surgery or date of death from any cause, whichever came first
Total Bilirubin (mg/dL)
Time frame: Measured at 1 day and 2 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Negmeldeen Mamoun, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Acetaminophen in people with Pain, run by The Cleveland Clinic 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 15 May 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Opioid Consumption (time frame: End of surgery through 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.