Equality Study of Ofirmev vs Oral Acetaminophen

NCT01711229 | Unknown Phase 4

• 1 other identifier: Ofirmev
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

oral acetaminophen; IV acetaminophen; Ofirmev; equianalgesic; arthroscopic rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• Primary outcome will measure total opioid consumption while the patient is in the PACU

  opioid consumption will be evaluated by the postoperative nurses who are blinded to the study groups

  From arrival in the recovery room until discharged from the recovery to home, which is an estimated time period of 2 hours

Secondary Outcomes (1)

• time from PACU admission to request for first opioid dose

  from admission into the recovery room until the patient is discharged to home which is an estimated average of 2 hours

Other Outcomes (1)

• Nominal pain scores

  from admission into the recovery room until discharged to home which is an estimated average of 2 hours

Study Arms (2)

Group I: IV acetaminophen

ACTIVE COMPARATOR

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

group 2

ACTIVE COMPARATOR

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

Interventions

IV acetaminophen DRUG

Ofirmev will be given 15 minutes prior to going to the OR

Also known as: Ofirmev

Group I: IV acetaminophen

oral acetaminophen DRUG

oral acetaminophen will be given preoperatively

Also known as: tylenol

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Babiash, Kimberly H., M.D.: lead

Study Sites (1)

Surgicare of Wichita

Wichita, Kansas, 67208, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Kimberly H Babiash, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly H Babiash, MD

CONTACT

806-543-6589; kbabiash@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 22, 2012
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 28, 2015

Record last verified: 2015-01

Locations

US (1)