<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711229</url>
  </required_header>
  <id_info>
    <org_study_id>Ofirmev</org_study_id>
    <nct_id>NCT01711229</nct_id>
  </id_info>
  <brief_title>Equality Study of Ofirmev vs Oral Acetaminophen</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Babiash, Kimberly H., M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Babiash, Kimberly H., M.D.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acetaminophen (Tylenol) is a drug that is used commonly for relief of mild to moderate pain.&#xD;
      It is found in many pain medicines that people take after having surgery. Narcotics are other&#xD;
      drugs also used for pain (examples of narcotics are morphine and related pain medications).&#xD;
      Medical science knows for a fact that acetaminophen works well when taken with narcotics for&#xD;
      moderate to severe pain. Recently, acetaminophen has become available in an intravenous (IV)&#xD;
      form called Ofirmev®. The IV form means that acetaminophen can be given into a vein. The&#xD;
      benefits of getting medicine from an IV include:&#xD;
&#xD;
        -  making the medicine work quickly&#xD;
&#xD;
        -  less medicine having to pass through the liver to be changed into a form that your body&#xD;
           can process The investigators know that acetaminophen is helpful for pain relief at the&#xD;
           time of surgery and after surgery. Acetaminophen is a very popular drug in outpatient&#xD;
           surgery for pain control when patients go home. The patient's surgeon uses it to control&#xD;
           pain after surgery at home in the form of Lortab or Percocet (Lortab and Percocet also&#xD;
           have a narcotic medicine that mixes with acetaminophen). Also, currently at Surgicare,&#xD;
           some anesthesiologists give intravenous acetaminophen while the patient is waiting to go&#xD;
           to surgery. The investigators currently do not give any patient acetaminophen by mouth&#xD;
           BEFORE surgery. However, since the addition of the IV form to the drug market, there has&#xD;
           been interest to see if the oral form is just as good or better in reducing pain after&#xD;
           surgery. This is why we are asking patients to join our study. The goal of this study is&#xD;
           to find out if the oral form (by mouth) or the IV form (given into a vein) of&#xD;
           acetaminophen controls pain after surgery better.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The American Society of Anesthesiologists recommends acetaminophen, NSAIDS, or COX-2&#xD;
      inhibitors as part of a multimodal pain management strategy to limit opioid usage (1). As the&#xD;
      surgical patient population becomes more complex with comorbidities ranging from obesity,&#xD;
      obstructive sleep apnea , and asthma becoming more common, the medical community continues to&#xD;
      search for efficacious analgesics with a high safety profile. While non-steroidal&#xD;
      anti-inflammatory drugs play an important role in multi-modal analgesia, their use is limited&#xD;
      based on concerns for platelet inhibition, asthma exacerbation, and renal artery perfusion in&#xD;
      patients of advanced age or reduced creatinine clearance.&#xD;
&#xD;
      Acetaminophen has proven to be an important analgesic in the perioperative setting. It is&#xD;
      frequently combined with opiates to allow for synergism, or it can be used as a sole&#xD;
      analgesic to provide up to 4 hours of relief for moderate pain. While acetaminophen's main&#xD;
      role as a multimodal analgesic regimen has been in tablet form as an opioid/acetaminophen&#xD;
      combination in the post- anesthesia care unit (PACU), acetaminophen has emerged as an&#xD;
      important perioperative analgesic due to FDA approval of an intravenous (IV) formulation&#xD;
      (Ofirmev®) in the United States in 2010. While the new intravenous formulation was approved&#xD;
      based upon its postoperative effectiveness and safety, there is also an interest in its&#xD;
      preoperative use. [12, 13] The benefit IV acetaminophen claims over the oral modality is a&#xD;
      70% higher blood concentration than a single similar dose (1 gram) of oral acetaminophen and&#xD;
      a rapid onset with peak blood concentration within 15 minutes of infusion while similar oral&#xD;
      doses may take 90 minutes to reach peak plasma concentrations. Many studies have compared the&#xD;
      IV formulation of acetaminophen (Ofirmev®) with the oral formulation at the same dose of 1&#xD;
      gram. However, this does not take into account the difference in pharmacokinetics of oral and&#xD;
      intravenous formulations. A 15-minute constant infusion of 1 gram acetaminophen resulted in&#xD;
      an average plasma concentration of 25.02 μg/ml at the end of the infusion with subsequent&#xD;
      decline to approximately 11 μg/ml at 1 hour and 7 μg/ml at 3 hour after the start of&#xD;
      infusion. Pain scores were lowest at one hour but remained significantly low for at least&#xD;
      three hours. [FDA med review] Moreover, the pharmacokinetics of the immediate release oral&#xD;
      formulation of acetaminophen are well-known. The absorption half life for acetaminophen in&#xD;
      healthy subjects ranges from 0.06-0.7 hours (8). The relative bioavailability ranges from 85%&#xD;
      to 98%. Moreover, it has a low first pass metabolism with a hepatic extraction ratio of 0.11&#xD;
      to 0.37 (9). After oral administration of 1 gram acetaminophen in the immediate release&#xD;
      formulation (IR), peak concentrations of acetaminophen in adults ranged from 7.7 to 17.6&#xD;
      μg/mL within 1 hour.&#xD;
&#xD;
      Although the therapeutic range for acetaminophen is not well established, plasma&#xD;
      concentrations of 10-20 mcg/ml are associated with antipyretic activity, and previous work&#xD;
      has assumed that antipyretic and analgesic doses will be similar. (3-4). However, another&#xD;
      study developed two compartmental pharmacokinetic/pharmacodynamic models to relate plasma&#xD;
      concentration to pain score relationship in children who received oral acetaminophen 30&#xD;
      minutes before outpatient tonsillectomy. The model demonstrated only a one point decrease in&#xD;
      pain score when the concentration increased from 10 μg/mL to 20 μg/mL and a steep loss of&#xD;
      pain protection when the concentration fell below 6 - 7 μg/mL. Therefore, this study&#xD;
      indicates a saturation of the analgesic effect of acetaminophen at a threshold plasma&#xD;
      concentration of as low as 7 μg/mL.&#xD;
&#xD;
      The basis for our proposal stems from a recent study by J Van Der Westhuizen, et al. They set&#xD;
      out to determine if the traditional one gram unit dose reached adequate serum concentrations&#xD;
      of greater than 10 mcg/ml. They compared 1 gram each of intravenous (IV) and oral&#xD;
      acetaminophen to see if one or both achieved therapeutic plasma concentrations&#xD;
      peri-operatively and for how long. This study questioned the use of oral acetaminophen at 1&#xD;
      gram because if it was not achieving therapeutic concentrations, the patients were not&#xD;
      getting optimal care (5). From this study, they were able to extrapolate oral doses of 20&#xD;
      mg/kg that would achieve a maximum concentration of 19 mcg/ml (which is the median maximum&#xD;
      concentration achieved by IV acetaminophen). The study concluded that for subjects over 75&#xD;
      kg, an effective IV equivalent oral acetaminophen dose would be 1.5 grams or even 2 grams if&#xD;
      the subject exceeded 100 kg (5). This study further recommended a follow up study to evaluate&#xD;
      these higher doses of oral acetaminophen as it relates to pain scores and rescue medications&#xD;
      postoperatively compared to the IV dose of 1 gram. The current unit dose of oral&#xD;
      acetaminophen is 1 gram every 6 hours. However, many studies have evaluated the effects of&#xD;
      higher doses of oral acetaminophen as well (10, 11). One study supported the use of 5-6 grams&#xD;
      of acetaminophen in a 24- hour period in order to reduce requirements for postoperative&#xD;
      morphine. requirements (6). Another study measured serum and CSF concentrations one hour&#xD;
      after administration of 500 mg, 1 gm, 1.5 gm, or 2 gm of oral acetaminophen (7).&#xD;
&#xD;
      In summary, the investigator's hypothesis is that while a similar dose is less effective, a&#xD;
      1.5 gram dose of oral acetaminophen (as determined by the extrapolation of maximum serum&#xD;
      concentrations from the Van Der Westhuizen, et al. study (5)) may be as effective as 1.0 gram&#xD;
      of IV acetaminophen in reducing postoperative pain scores and total opioid consumption, thus&#xD;
      resulting in lower cost to the patient and provider.&#xD;
&#xD;
      II. Specific Aims:&#xD;
&#xD;
      The investigator's aim is to compare the effects of a 1.5 gram oral acetaminophen to 1 gram&#xD;
      IV acetaminophen when given preoperatively to patients undergoing arthroscopic rotator cuff&#xD;
      repair by a single surgeon at a single facility. The primary outcomes will evaluate total&#xD;
      opioid consumption in the post anesthesia care unit PACU and nominal pain scores. The&#xD;
      investigators theorize that 1.5 grams of oral acetaminophen will be as efficacious as 1 gram&#xD;
      IV acetaminophen resulting in lower costs to the patient and provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2015</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome will measure total opioid consumption while the patient is in the PACU</measure>
    <time_frame>From arrival in the recovery room until discharged from the recovery to home, which is an estimated time period of 2 hours</time_frame>
    <description>opioid consumption will be evaluated by the postoperative nurses who are blinded to the study groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time from PACU admission to request for first opioid dose</measure>
    <time_frame>from admission into the recovery room until the patient is discharged to home which is an estimated average of 2 hours</time_frame>
    <description>post operative nurses will record time to request for first opioid</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Nominal pain scores</measure>
    <time_frame>from admission into the recovery room until discharged to home which is an estimated average of 2 hours</time_frame>
    <description>post operative nurses will assess pain scores from 1-10 in 5 minute intervals and follow a pain intervention protocol</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">114</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Group I: IV acetaminophen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group I will receive 1 gram IV acetaminophen 15 minutes prior to going to the operating room for arthroscopic rotator cuff repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 will receive 1.5grams of oral acetaminophen immediately prior to proceeding to the operation groom for arthroscopic rotator cuff surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IV acetaminophen</intervention_name>
    <description>Ofirmev will be given 15 minutes prior to going to the OR</description>
    <arm_group_label>Group I: IV acetaminophen</arm_group_label>
    <other_name>Ofirmev</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oral acetaminophen</intervention_name>
    <description>oral acetaminophen will be given preoperatively</description>
    <arm_group_label>group 2</arm_group_label>
    <other_name>tylenol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18&#xD;
&#xD;
          -  Weight 75kg -120 kg&#xD;
&#xD;
          -  Undergoing arthroscopic rotator cuff repair by same surgeon at Surgicare of Wichita&#xD;
&#xD;
          -  Patients who sign informed consent&#xD;
&#xD;
          -  Patients who do not meet any of the exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 yrs (will reduce risk of overdosing oral acetaminophen)&#xD;
&#xD;
          -  History of opioid abuse or chronic opioid use greater than 3 months (may skew data&#xD;
             with regards to pain control due to the concept of tolerance)&#xD;
&#xD;
          -  Acetaminophen allergy (avoids risk of allergic reaction)&#xD;
&#xD;
          -  Liver disease as determined by anesthesiologist by history (acetaminophen involves the&#xD;
             liver for metabolism, therefore, if the liver is not functioning appropriately, doses&#xD;
             could accumulate and cause damage.)&#xD;
&#xD;
          -  Daily alcohol consumption (same explanation as for liver disease)&#xD;
&#xD;
          -  Renal failure (patient on dialysis or health history indicates renal dysfunction)&#xD;
             (acetaminophen has some renal excretion)&#xD;
&#xD;
          -  Asthma (recent concerns for acetaminophen leading to asthma exacerbations)&#xD;
&#xD;
          -  Any other contraindication to taking acetaminophen&#xD;
&#xD;
          -  Surgeon requested pre-operative Interscalene block (this will cause the patient to&#xD;
             cease having pain, therefore the effects of acetaminophen reducing pain scores will&#xD;
             not be able to be evaluated)&#xD;
&#xD;
          -  Current warfarin, carbamazepine, or phenytoin use (these medications can accumulate in&#xD;
             the presence of excessive acetaminophen use or may harm the liver and affect&#xD;
             acetaminophen use or may harm the liver and affect acetaminophen concentrations).&#xD;
&#xD;
          -  Weight greater than 120 kg (1.5 gram doses of acetaminophen may be too low to&#xD;
             appropriately evaluate the effects in this patient population)&#xD;
&#xD;
          -  Patients scheduled for &quot;possible rotator cuff repair&quot; (including these patients in our&#xD;
             studies could skew enrollment numbers should a rotator cuff repair not be done, so&#xD;
             these patients will be screened and excluded prior to enrollments)&#xD;
&#xD;
          -  Any consumption of acetaminophen containing products in the 24 hour period prior to&#xD;
             surgery (excluded because acetaminophen can induce its own metabolism, therefore&#xD;
             reducing serum concentrations)&#xD;
&#xD;
          -  Any significant medical disease(s), laboratory abnormalities or condition(s) that in&#xD;
             the Investigator's judgment could compromise the subject's welfare, ability to&#xD;
             communicate with the study staff, complete study activities, or would otherwise&#xD;
             contraindicate study participation.&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Patients who are not able to consent for themselves.&#xD;
&#xD;
          -  pregnant patients (All female patients of childbearing potential are given a pregnancy&#xD;
             test prior to any elective surgery at Surgicare. Though acetaminophen is NOT harmful&#xD;
             to these patients, they will be excluded given the fact that elective surgery in&#xD;
             itself is contraindicated in pregnancy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly H Babiash, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Kimberly H Babiash, MD</last_name>
    <phone>806-543-6589</phone>
    <email>kbabiash@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Surgicare of Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Gerry Bassell, MD</last_name>
      <phone>316-685-2207</phone>
    </contact>
    <investigator>
      <last_name>Kimberly H Babiash, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oral acetaminophen</keyword>
  <keyword>IV acetaminophen</keyword>
  <keyword>Ofirmev</keyword>
  <keyword>equianalgesic</keyword>
  <keyword>arthroscopic rotator cuff repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711229
org study id: Ofirmev
nct id: NCT01711229
lead sponsor: 
has dmc: No
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.
The American Society of Anesthesiologists recommends acetaminophen, NSAIDS, or COX-2
      inhibitors as part of a multimodal pain management strategy to limit opioid usage (1). As the
      surgical patient population becomes more complex with comorbidities ranging from obesity,
      obstructive sleep apnea , and asthma becoming more common, the medical community continues to
      search for efficacious analgesics with a high safety profile. While non-steroidal
      anti-inflammatory drugs play an important role in multi-modal analgesia, their use is limited
      based on concerns for platelet inhibition, asthma exacerbation, and renal artery perfusion in
      patients of advanced age or reduced creatinine clearance.

      Acetaminophen has proven to be an important analgesic in the perioperative setting. It is
      frequently combined with opiates to allow for synergism, or it can be used as a sole
      analgesic to provide up to 4 hours of relief for moderate pain. While acetaminophen's main
      role as a multimodal analgesic regimen has been in tablet form as an opioid/acetaminophen
      combination in the post- anesthesia care unit (PACU), acetaminophen has emerged as an
      important perioperative analgesic due to FDA approval of an intravenous (IV) formulation
      (Ofirmev®) in the United States in 2010. While the new intravenous formulation was approved
      based upon its postoperative effectiveness and safety, there is also an interest in its
      preoperative use. [12, 13] The benefit IV acetaminophen claims over the oral modality is a
      70% higher blood concentration than a single similar dose (1 gram) of oral acetaminophen and
      a rapid onset with peak blood concentration within 15 minutes of infusion while similar oral
      doses may take 90 minutes to reach peak plasma concentrations. Many studies have compared the
      IV formulation of acetaminophen (Ofirmev®) with the oral formulation at the same dose of 1
      gram. However, this does not take into account the difference in pharmacokinetics of oral and
      intravenous formulations. A 15-minute constant infusion of 1 gram acetaminophen resulted in
      an average plasma concentration of 25.02 μg/ml at the end of the infusion with subsequent
      decline to approximately 11 μg/ml at 1 hour and 7 μg/ml at 3 hour after the start of
      infusion. Pain scores were lowest at one hour but remained significantly low for at least
      three hours. [FDA med review] Moreover, the pharmacokinetics of the immediate release oral
      formulation of acetaminophen are well-known. The absorption half life for acetaminophen in
      healthy subjects ranges from 0.06-0.7 hours (8). The relative bioavailability ranges from 85%
      to 98%. Moreover, it has a low first pass metabolism with a hepatic extraction ratio of 0.11
      to 0.37 (9). After oral administration of 1 gram acetaminophen in the immediate release
      formulation (IR), peak concentrations of acetaminophen in adults ranged from 7.7 to 17.6
      μg/mL within 1 hour.

      Although the therapeutic range for acetaminophen is not well established, plasma
      concentrations of 10-20 mcg/ml are associated with antipyretic activity, and previous work
      has assumed that antipyretic and analgesic doses will be similar. (3-4). However, another
      study developed two compartmental pharmacokinetic/pharmacodynamic models to relate plasma
      concentration to pain score relationship in children who received oral acetaminophen 30
      minutes before outpatient tonsillectomy. The model demonstrated only a one point decrease in
      pain score when the concentration increased from 10 μg/mL to 20 μg/mL and a steep loss of
      pain protection when the concentration fell below 6 - 7 μg/mL. Therefore, this study
      indicates a saturation of the analgesic effect of acetaminophen at a threshold plasma
      concentration of as low as 7 μg/mL.

      The basis for our proposal stems from a recent study by J Van Der Westhuizen, et al. They set
      out to determine if the traditional one gram unit dose reached adequate serum concentrations
      of greater than 10 mcg/ml. They compared 1 gram each of intravenous (IV) and oral
      acetaminophen to see if one or both achieved therapeutic plasma concentrations
      peri-operatively and for how long. This study questioned the use of oral acetaminophen at 1
      gram because if it was not achieving therapeutic concentrations, the patients were not
      getting optimal care (5). From this study, they were able to extrapolate oral doses of 20
      mg/kg that would achieve a maximum concentration of 19 mcg/ml (which is the median maximum
      concentration achieved by IV acetaminophen). The study concluded that for subjects over 75
      kg, an effective IV equivalent oral acetaminophen dose would be 1.5 grams or even 2 grams if
      the subject exceeded 100 kg (5). This study further recommended a follow up study to evaluate
      these higher doses of oral acetaminophen as it relates to pain scores and rescue medications
      postoperatively compared to the IV dose of 1 gram. The current unit dose of oral
      acetaminophen is 1 gram every 6 hours. However, many studies have evaluated the effects of
      higher doses of oral acetaminophen as well (10, 11). One study supported the use of 5-6 grams
      of acetaminophen in a 24- hour period in order to reduce requirements for postoperative
      morphine. requirements (6). Another study measured serum and CSF concentrations one hour
      after administration of 500 mg, 1 gm, 1.5 gm, or 2 gm of oral acetaminophen (7).

      In summary, the investigator's hypothesis is that while a similar dose is less effective, a
      1.5 gram dose of oral acetaminophen (as determined by the extrapolation of maximum serum
      concentrations from the Van Der Westhuizen, et al. study (5)) may be as effective as 1.0 gram
      of IV acetaminophen in reducing postoperative pain scores and total opioid consumption, thus
      resulting in lower cost to the patient and provider.

      II. Specific Aims:

      The investigator's aim is to compare the effects of a 1.5 gram oral acetaminophen to 1 gram
      IV acetaminophen when given preoperatively to patients undergoing arthroscopic rotator cuff
      repair by a single surgeon at a single facility. The primary outcomes will evaluate total
      opioid consumption in the post anesthesia care unit PACU and nominal pain scores. The
      investigators theorize that 1.5 grams of oral acetaminophen will be as efficacious as 1 gram
      IV acetaminophen resulting in lower costs to the patient and provider.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
description: opioid consumption will be evaluated by the postoperative nurses who are blinded to the study groups
measure: 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
description: post operative nurses will record time to request for first opioid
measure: Nominal pain scores
time frame: from admission into the recovery room until discharged to home which is an estimated average of 2 hours
description: post operative nurses will assess pain scores from 1-10 in 5 minute intervals and follow a pain intervention protocol
arm group label: Group I: IV acetaminophen
arm group type: Active Comparator
description: Group I will receive 1 gram IV acetaminophen 15 minutes prior to going to the operating room for arthroscopic rotator cuff repair
arm group label: group 2
arm group type: Active Comparator
description: Group 2 will receive 1.5grams of oral acetaminophen immediately prior to proceeding to the operation groom for arthroscopic rotator cuff surgery
intervention type: Drug
intervention name: IV acetaminophen
description: Ofirmev will be given 15 minutes prior to going to the OR
arm group label: Group I: IV acetaminophen
other name: Ofirmev
intervention type: Drug
intervention name: oral acetaminophen
description: oral acetaminophen will be given preoperatively
arm group label: group 2
other name: tylenol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kimberly H Babiash, MD
role: Principal Investigator
last name: Kimberly H Babiash, MD
phone: 806-543-6589
email: kbabiash@gmail.com
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Acetaminophen