The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.
• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients Secondary Objectives: * To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment * To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment * To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment * To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
213
Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
Arcadia Methodist Hospital
Arcadia, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Accurate Clinical Trials, Inc.
Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE).
Number of subjects who experienced at least one treatment emergent adverse event (TEAE). A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
Time frame: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up
Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
Serious TEAE is any untoward medical occurrences at any dose of study medication that: * results in death * is life threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event
Time frame: First dose (T0) to within 30 days of the last dose of study medication.
Subject Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments
Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with side effects related to study treatment at End of Day 5 (prior to discharge)
Time frame: End of Day 5 (prior to discharge)
Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.
Using a four point categorical scale 0= poor, 1= fair, 2= good, 3= excellent, comparisons of subject's Global Evaluations of the level of satisfaction with study treatments looking back over the entire treatment period was conducted at Day 7.
Time frame: Study period lookback at Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Laguna Hills, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Lotus Clinical Research, Inc.
Pasadena, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Nature Coast Clinical Research
Crystal River, Florida, United States
G&G Research
Ft. Pierce, Florida, United States
University of Miami School of Medicine
Miami, Florida, United States
Weill Medical College of Cornell University
New York, New York, United States
...and 4 more locations