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Equality Study of Ofirmev vs Oral Acetaminophen

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. Identifier: NCT01711229
Recruitment Status : Unknown
Verified January 2015 by Babiash, Kimberly H., M.D..
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2012
Last Update Posted : January 28, 2015
Information provided by (Responsible Party):
Babiash, Kimberly H., M.D.

Brief Summary:

Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain. It is found in many pain medicines that people take after having surgery. Narcotics are other drugs also used for pain (examples of narcotics are morphine and related pain medications). Medical science knows for a fact that acetaminophen works well when taken with narcotics for moderate to severe pain. Recently, acetaminophen has become available in an intravenous (IV) form called Ofirmev®. The IV form means that acetaminophen can be given into a vein. The benefits of getting medicine from an IV include:

  • making the medicine work quickly
  • less medicine having to pass through the liver to be changed into a form that your body can process The investigators know that acetaminophen is helpful for pain relief at the time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient surgery for pain control when patients go home. The patient's surgeon uses it to control pain after surgery at home in the form of Lortab or Percocet (Lortab and Percocet also have a narcotic medicine that mixes with acetaminophen). Also, currently at Surgicare, some anesthesiologists give intravenous acetaminophen while the patient is waiting to go to surgery. The investigators currently do not give any patient acetaminophen by mouth BEFORE surgery. However, since the addition of the IV form to the drug market, there has been interest to see if the oral form is just as good or better in reducing pain after surgery. This is why we are asking patients to join our study. The goal of this study is to find out if the oral form (by mouth) or the IV form (given into a vein) of acetaminophen controls pain after surgery better.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: IV acetaminophen Drug: oral acetaminophen Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Equivalence Trial Comparing the Analgesic Efficacy of Ofirmev® Compared to a 1.5 Gram Dose of Oral Acetaminophen for Arthroscopic Rotator Cuff Repair
Study Start Date : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Group I: IV acetaminophen
Group I will receive 1 gram IV acetaminophen 15 minutes prior to going to the operating room for arthroscopic rotator cuff repair
Drug: IV acetaminophen
Ofirmev will be given 15 minutes prior to going to the OR
Other Name: Ofirmev

Active Comparator: group 2
Group 2 will receive 1.5grams of oral acetaminophen immediately prior to proceeding to the operation groom for arthroscopic rotator cuff surgery
Drug: oral acetaminophen
oral acetaminophen will be given preoperatively
Other Name: tylenol

Primary Outcome Measures :
  1. Primary outcome will measure total opioid consumption while the patient is in the PACU [ Time Frame: From arrival in the recovery room until discharged from the recovery to home, which is an estimated time period of 2 hours ]
    opioid consumption will be evaluated by the postoperative nurses who are blinded to the study groups

Secondary Outcome Measures :
  1. time from PACU admission to request for first opioid dose [ Time Frame: from admission into the recovery room until the patient is discharged to home which is an estimated average of 2 hours ]
    post operative nurses will record time to request for first opioid

Other Outcome Measures:
  1. Nominal pain scores [ Time Frame: from admission into the recovery room until discharged to home which is an estimated average of 2 hours ]
    post operative nurses will assess pain scores from 1-10 in 5 minute intervals and follow a pain intervention protocol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age ≥18
  • Weight 75kg -120 kg
  • Undergoing arthroscopic rotator cuff repair by same surgeon at Surgicare of Wichita
  • Patients who sign informed consent
  • Patients who do not meet any of the exclusion criteria

Exclusion Criteria:

  • Age < 18 yrs (will reduce risk of overdosing oral acetaminophen)
  • History of opioid abuse or chronic opioid use greater than 3 months (may skew data with regards to pain control due to the concept of tolerance)
  • Acetaminophen allergy (avoids risk of allergic reaction)
  • Liver disease as determined by anesthesiologist by history (acetaminophen involves the liver for metabolism, therefore, if the liver is not functioning appropriately, doses could accumulate and cause damage.)
  • Daily alcohol consumption (same explanation as for liver disease)
  • Renal failure (patient on dialysis or health history indicates renal dysfunction) (acetaminophen has some renal excretion)
  • Asthma (recent concerns for acetaminophen leading to asthma exacerbations)
  • Any other contraindication to taking acetaminophen
  • Surgeon requested pre-operative Interscalene block (this will cause the patient to cease having pain, therefore the effects of acetaminophen reducing pain scores will not be able to be evaluated)
  • Current warfarin, carbamazepine, or phenytoin use (these medications can accumulate in the presence of excessive acetaminophen use or may harm the liver and affect acetaminophen use or may harm the liver and affect acetaminophen concentrations).
  • Weight greater than 120 kg (1.5 gram doses of acetaminophen may be too low to appropriately evaluate the effects in this patient population)
  • Patients scheduled for "possible rotator cuff repair" (including these patients in our studies could skew enrollment numbers should a rotator cuff repair not be done, so these patients will be screened and excluded prior to enrollments)
  • Any consumption of acetaminophen containing products in the 24 hour period prior to surgery (excluded because acetaminophen can induce its own metabolism, therefore reducing serum concentrations)
  • Any significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the subject's welfare, ability to communicate with the study staff, complete study activities, or would otherwise contraindicate study participation.
  • Non-English speaking patients
  • Patients who are not able to consent for themselves.
  • pregnant patients (All female patients of childbearing potential are given a pregnancy test prior to any elective surgery at Surgicare. Though acetaminophen is NOT harmful to these patients, they will be excluded given the fact that elective surgery in itself is contraindicated in pregnancy)

Information from the National Library of Medicine

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 identifier (NCT number): NCT01711229

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Contact: Kimberly H Babiash, MD 806-543-6589

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United States, Kansas
Surgicare of Wichita
Wichita, Kansas, United States, 67208
Contact: Gerry Bassell, MD    316-685-2207      
Principal Investigator: Kimberly H Babiash, MD         
Sponsors and Collaborators
Babiash, Kimberly H., M.D.
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Principal Investigator: Kimberly H Babiash, MD
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Responsible Party: Babiash, Kimberly H., M.D. Identifier: NCT01711229    
Other Study ID Numbers: Ofirmev
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: January 28, 2015
Last Verified: January 2015
Keywords provided by Babiash, Kimberly H., M.D.:
oral acetaminophen
IV acetaminophen
arthroscopic rotator cuff repair
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs