Equality Study of Ofirmev vs Oral Acetaminophen

Status unconfirmed · Phase 4

Conditions studied: Pain, Postoperative

In brief

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.

Key facts

Study ID

NCT01711229

Run by

Babiash, Kimberly H., M.D.

People needed

114

Starts

2015-12-01

Expected to finish

2016-12-01

Last updated by the study team

2015-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Surgicare of Wichita — Wichita, Kansas, United States

Full record on ClinicalTrials.gov

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