Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever

Acetaminophen in Combination With N-Acetylcysteine (NAC) vs. Placebo in the Treatment of Fever: A Double-Blind, Randomized Control Study

The purpose of this study is to compare the efficacy of the an N-acetyl-p-aminophenol (APAP, also known as acetaminophen) and N-acetylcysteine (NAC) combination versus an APAP-placebo combination as an anti-pyretic agent.

N-acetyl-p-aminophenol (APAP), or more commonly known as acetaminophen in the United States, accounts for more overdose and overdose deaths in the United States and United Kingdom than any other pharmaceutical agent. If N-acetylcysteine (NAC) is given within 8 to 10 hours of APAP ingestion, it has been shown to prevent serious liver failure and death in the setting of overdoses. Therefore, it may be beneficial to administer APAP in combination with NAC routinely to reduce rates of liver failure and death. Because NAC's main role is to reduce the accumulation of APAP's toxic metabolites, the concomitant administration of NAC should have no impact on the efficacy of APAP as an antipyretic and analgesic. Thus, we propose a single-center, non-inferiority randomized control study comparing the efficacy of the APAP-NAC combination as compared to APAP-placebo as an anti-pyretic agent.

Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo

Difference in liver function tests after study drug administration between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo

Change in serum total protein (TP), albumin (Alb), total bilirubin (TB), direct bilirubin (DB), amino alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatate (AP) levels before and after the study drug administration.

Inclusion Criteria: adults aged 18 to 75 years old admitted to an inpatient unit at Columbia-Presbyterian Medical Center fever defined as an oral temperature of 38.5°C Exclusion Criteria: if oral temperature cannot be obtained abnormal aminotransferase levels prior adverse reaction to acetaminophen or N-acetylcysteine

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