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Acetaminophen overdose: a 48-hour intravenous N-acetylcysteine treatment protocol.

Abstract

STUDY OBJECTIVE

To determine the safety and efficacy of a 48-hour IV N-acetylcysteine (IV NAC) treatment protocol for acute acetaminophen overdose.

DESIGN

Nonrandomized trial open to all eligible patients.

SETTING

Multicenter; hospitals included moderate- and high-volume private, university, and municipal hospitals in urban and suburban settings.

TYPE OF PARTICIPANTS

Two hundred twenty-three patients were entered. Of these, 179 met inclusion criteria: acute acetaminophen overdose, plasma acetaminophen concentration above the treatment nomogram line, treatment with IV NAC according to the protocol, and sufficient data to determine outcome.

INTERVENTIONS

IV NAC treatment consisted of a loading dose of 140 mg/kg followed by 12 doses of 70 mg/kg every four hours.

MEASUREMENTS AND MAIN RESULTS

Patients were grouped for analysis according to risk group based on the initial plasma acetaminophen concentration. Hepatotoxicity (aspartate aminotransferase or alanine aminotransferase of more than 1,000 IU/L) developed in 10% (five of 50) of patients at "probable risk" when IV NAC was started within ten hours of acetaminophen ingestion and in 27.1% (23 of 85) when therapy was begun after ten to 24 hours. Among "high-risk" patients first treated 16 to 24 hours after overdose, hepatotoxicity occurred in 57.9% (11 of 19). There were two deaths (two of 179, 1.1%). Adverse reactions resulting from NAC occurred in 32 of 223 cases (14.3%), consisting in 29 of 32 patients (91% of reactions) of transient, patchy, skin erythema or mild urticaria during the loading dose that did not require discontinuation of therapy.

CONCLUSION

This 48-hour IV NAC protocol is safe and effective antidotal therapy for acetaminophen overdose. Based on available data, it is equal to 72-hour oral and 20-hour IV treatment protocols when started early and superior to the 20-hour IV regimen when treatment is delayed. Further study will be required to determine its relative efficacy in the high-risk patient treated very late.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Section of Trauma and Emergency Medicine, University of Colorado Health Sciences Center, Denver.

    , , , ,

    Source

    Annals of emergency medicine 20:10 1991 Oct pg 1058-63

    MeSH

    Acetaminophen
    Acetylcysteine
    Adolescent
    Adult
    Child
    Drug Overdose
    Female
    Humans
    Injections, Intravenous
    Liver
    Male
    Prospective Studies
    Risk Factors
    Time Factors

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    1928874

    Citation

    TY - JOUR T1 - Acetaminophen overdose: a 48-hour intravenous N-acetylcysteine treatment protocol. AU - Smilkstein,M J, AU - Bronstein,A C, AU - Linden,C, AU - Augenstein,W L, AU - Kulig,K W, AU - Rumack,B H, PY - 1991/10/1/pubmed PY - 1991/10/1/medline PY - 1991/10/1/entrez SP - 1058 EP - 63 JF - Annals of emergency medicine JO - Ann Emerg Med VL - 20 IS - 10 N2 - STUDY OBJECTIVE: To determine the safety and efficacy of a 48-hour IV N-acetylcysteine (IV NAC) treatment protocol for acute acetaminophen overdose. DESIGN: Nonrandomized trial open to all eligible patients. SETTING: Multicenter; hospitals included moderate- and high-volume private, university, and municipal hospitals in urban and suburban settings. TYPE OF PARTICIPANTS: Two hundred twenty-three patients were entered. Of these, 179 met inclusion criteria: acute acetaminophen overdose, plasma acetaminophen concentration above the treatment nomogram line, treatment with IV NAC according to the protocol, and sufficient data to determine outcome. INTERVENTIONS: IV NAC treatment consisted of a loading dose of 140 mg/kg followed by 12 doses of 70 mg/kg every four hours. MEASUREMENTS AND MAIN RESULTS: Patients were grouped for analysis according to risk group based on the initial plasma acetaminophen concentration. Hepatotoxicity (aspartate aminotransferase or alanine aminotransferase of more than 1,000 IU/L) developed in 10% (five of 50) of patients at "probable risk" when IV NAC was started within ten hours of acetaminophen ingestion and in 27.1% (23 of 85) when therapy was begun after ten to 24 hours. Among "high-risk" patients first treated 16 to 24 hours after overdose, hepatotoxicity occurred in 57.9% (11 of 19). There were two deaths (two of 179, 1.1%). Adverse reactions resulting from NAC occurred in 32 of 223 cases (14.3%), consisting in 29 of 32 patients (91% of reactions) of transient, patchy, skin erythema or mild urticaria during the loading dose that did not require discontinuation of therapy. CONCLUSION: This 48-hour IV NAC protocol is safe and effective antidotal therapy for acetaminophen overdose. Based on available data, it is equal to 72-hour oral and 20-hour IV treatment protocols when started early and superior to the 20-hour IV regimen when treatment is delayed. Further study will be required to determine its relative efficacy in the high-risk patient treated very late. SN - 0196-0644 UR - https://www.unboundmedicine.com/medline/citation/1928874/abstract/Acetaminophen_overdose:_a_48_hour_intravenous_N_acetylcysteine_treatment_protocol_ L2 - http://linkinghub.elsevier.com/retrieve/pii/S0196-0644(05)81352-6 ER -