Conditions: Acute Pain Fever
Keywords: Acute pain Fever IV Acetaminophen Analgesic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 213
Healthy volunteers: no

Brief summary:
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.

Detailed description:
• 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

Arms:
arm 1: 1 g q6h IV Acetaminophen arm 2: 650 mg q4h IV Acetaminophen 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.

Interventions: intervention 1: IV Acetaminophen
Intervention descriptions: intervention 1: 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.

Protocol document: