None listed
Conditions
Brief summary
Paracetamol is one of the most common medications taken in overdose around the world. It is readily available and does not require a prescription to purchase. N-acetylcysteine (NAC) is the antidote used to treat patients at risk of developing liver toxicity secondary to the metabolites of paracetamol that accumulate following paracetamol overdose. The standard NAC treatment regimen lasts 20 to 21 hours and requires admission to hospital. Patients who present to hospital and receive NAC for paracetamol overdose and have normal liver function and subsequently have a less than therapeutic paracetamol concentration and normal liver function with at least 12 hours of treatment with NAC are unlikely to go on to develop liver toxicity. All study participants will be required to stay in hospital for the usual 20 hours (the time for a standard NAC infusion as per the current treatment guidelines) and will have liver function tests measured at this time. This trial aims to determine that a shorter treatment regimen (12 hrs) for paracetamol overdose is safe.
Interventions
N-acetylcysteine (NAC) given intravenously as 200mg/kg over 4 hours (infusion 1), then 100 mg/kg over 16 hour infusion rate (infusion 2) ie. at least half will be given e.g. 50mg/kg over 8 hours. Depending on 12 hour post initiation blood tests, infusion 2 may be ceased after at least 8 hours of infusion. ie . 12 hour protocol
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Healthy volunteers
No
Inclusion criteria
Inclusion criteria will be patients requiring NAC following paracetamol overdose presenting with single paracetamol and staggered ingestions with normal liver function tests (ALT <40 IU/L) and paracetamol concentration < 132 micromol/L (20 mg/L) after 12 hours of NAC.
Exclusion criteria
Exclusion criteria will be patients presenting with a history of supratherapeutic ingestion of paracetamol (>10grams over 24 hours, >6 grams/day over 48 hrs), intoxicated or sedated patients with co-ingested alcohol or sedating drugs, modified release paracetamol ingestion, patients with preexisting liver disease evidenced by abnormal liver function tests, and pregnancy. If the ALT is >40 IU/L or paracetamol concentration > 132 micromol/L (20 mg/L) after 12 hours of NAC, they will receive the full course of NAC and be excluded from the study.
Outcome results
None listed