Acetaminophen in Combination With NAC Versus Placebo in Treating Fever

Condition(s) targeted: Liver Failure; Liver Failure, Acute; Drug Induced Liver Injury; Prevention & Control; Fever

Intervention: APAP and NAC combination (Drug); APAP and Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Columbia University

Official(s) and/or principal investigator(s):
Matthew Chang, MD, Principal Investigator, Affiliation: Columbia University

Overall contact:
Matthew Chang, MD, Phone: 212-305-5138, Email: mc2787@columbia.edu

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: To determine the difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo

Secondary outcome: To determine the 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

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Matthew Chang, MD, Phone: 212-305-5138, Email: mc2787@columbia.edu

Columbia University Medical Center, New York, New York 10032, United States; Recruiting
Matthew Chang, MD, Phone: 212-305-5138, Email: mc2787@columbia.edu
Matthew Chang, MD, Principal Investigator

Acetaminophen overdose information from the NIH

Related publications:

Bronstein AC, Spyker DA, Cantilena LR Jr, Green J, Rumack BH, Heard SE. 2006 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS). Clin Toxicol (Phila). 2007 Dec;45(8):815-917.

Smilkstein MJ, Knapp GL, Kulig KW, Rumack BH. Efficacy of oral N-acetylcysteine in the treatment of acetaminophen overdose. Analysis of the national multicenter study (1976 to 1985) N Engl J Med. 1988 Dec 15;319(24):1557-62.

Vale JA, Proudfoot AT. Paracetamol (acetaminophen) poisoning. Lancet. 1995 Aug 26;346(8974):547-52. Review. No abstract available.

Starting date: July 2009
Last updated: February 2, 2011