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Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy.
Acetamenphen is an analgesic and antipyretic drug . It is used as an active ingredient in many over-the-counter and prescription medications. It is generally considered safe at therapeutic doses. However, toxicity can be caused by multiple supratherapeutic doses or an acute, high overdose .
Acetaminophen is metabolized by the cytochrome P450 2E1 to N-acetyl para- benzoquinone-imine (NAPQI), a metabolit extremely toxic to the liver. This process depletes glutathione; thus, NAPQI binds to cellular and mitochondrial proteins to form adducts, impairing mitochondrial respiration and generating oxidative stress .
N-Acetylcysteine (NAC) is a 20-21-hour regimen which involves 3 weight related infusions. The first 150mg/kg is given over 1 hour, second 50mg/kg given over 4 hours and the last 100mg/kg given over 16 hours. This has been the optimal available therapy since 1980 .
Several evidence shows various adverse effect of this regimen which include anaphylactoid reaction, nausea, vomiting and medication error .
Recently the intravenous regimen has been simplified from a three-bag regimen to a two-bag regimen in many parts of the world, which has reduced the early very high concentrations and therefore adverse reaction rate .
Different clinical studies have been carried out to propose the adoption of a shorter regimen, the Scottish and Newcastle Antiemetic Pre-treatment (SNAP) 12-hours NAC regimen into clinical practice .
The SNAP is a two-bag regimen which involves giving 100mg/kg infusion over 2hours, then last 200mg/kg infusion giving over 10hours .
The SNAP regimen confirms that it produces fewer adverse drug reactions (ADRs) and has similar efficacy with regard to preventing liver injury when compared to the 21 h NAC regimen. Further clinical development and adoption of the SNAP regimen could improve treatment safety for this patient group, potentially shorten the length of treatment without compromising antidote effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active Comparator |
| |
| patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active Comparator |
| |
| patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active Comparator |
| |
| patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evidence-based medical care for paracetamol toxicity | Other | adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) | 1-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment | 1- Day 2 |
| change in serum creatinine level | Mean change in serum creatinine (mg/dL) from baseline to end of treatment. | Day 2 |
| Incidence of adverse drug reactions | Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of clinical recovery | Number of participants who achieve complete clinical recovery without complications | immediately after the intervention |
| incidence of serious complications | Number of participants who develop fulminant hepatic failure, hepatic encephalopathy, coma, or hemorrhage. |
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Inclusion Criteria:
Exclusion Criteria:
* Co-ingestion of other hepatotoxic drugs .
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| sabreen rabee hasan | Contact | 00201141586524 | Sabreenrabee1998@gmail.com | |
| marwa khalifa mohmad | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Assiut University | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31311721 | Background | Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13. |
| Label | URL |
|---|---|
| Safety and Efficacy of the SNAP 12-hour Acetylcysteine Regimen for the Treatment of Paracetamol Overdose | View source |
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| Evidence-based medical care for paracetamol toxicity | Other | adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol |
|
| Evidence-based medical care for paracetamol toxicity | Other | adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol |
|
| Evidence-based medical care for paracetamol toxicity | Other | adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol |
|
| immediately after the intervention |