Acetaminophen in Combination With N-Acetylcysteine (NAC) Versus Placebo in Treating Fever
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: APAP and NAC combination N-acetyl-p-aminophenol and placebo (APAP-NAC) combination pill |
Drug: APAP and NAC combination
APAP 650mg and NAC 600mg combination oral tablet administered once
Other Names:
|
| Placebo Comparator: APAP and Placebo combination N-acetyl-p-aminophenol and placebo (APAP-placebo) combination pill |
Drug: APAP and Placebo
APAP 650mg and Placebo combination oral tablet administered once
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Difference in temperature reduction between participants who are administered combination N-acetyl-p-aminophenol and N-Acetylcysteine (APAP-NAC) versus combination APAP-placebo [6 hours after study drug administration]
Secondary Outcome Measures
- 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 [Within 24 hours of study drug administration]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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adults aged 18 to 75 years old
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admitted to an inpatient unit at Columbia-Presbyterian Medical Center
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fever defined as an oral temperature of 38.5°C
Exclusion Criteria:
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if oral temperature cannot be obtained
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abnormal aminotransferase levels
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prior adverse reaction to acetaminophen or N-acetylcysteine
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
Investigators
- Principal Investigator: Matthew Chang, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
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.
- AAAD4090