Underhill 1990.
Methods |
Study design: randomized controlled trial Study duration: recruitment period between April and October 1988 Setting: hospital setting: accident and emergency departments of two teaching hospitals Country: UK Number of individuals randomized: 60 Number of individuals receiving the intervention: Gastric lavage: 14 Acitvated charcoal: 20 Ipecac: 21 Number of individuals receiving the control: 5 Number of individuals lost to follow‐up: 0 Sample size calculated: |
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Participants |
Sex: 16 male and 44 female Age: mean (range): 25.7 (16‐62) years Country (if different from study authors'): NA Type, dose and timing of poisoning: participants presenting within 4 h after an overdose (mean delay: 123 min, range 30‐240 min) of at least 5 g paracetamol. 48 took paracetamol without another drug; 21 took paracetamol with alcohol Inclusion criteria: > 16 years, presenting < 4 h after intake, ingested > 5 g paracetamol Exclusion criteria: depressed conscious level, conditions that might preclude use of any one of the treatment methods |
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Interventions |
Intervention arm 1: Type: gastric lavage Timing: NA Dose: NA Frequency: NA Integrity: NA Intervention arm 2: Type: activated charcoal (Carbomix) Timing: no information Dose: AC:Drug ratio of 10:1 Frequency: 1× Integrity: 16 participants managed to take the recommended dose. 4 participants vomited and 1 refused to take more than one mouthful Intervention arm 3: Type: ipecac Timing: no information Dose: 30 mL Frequency: 1×, repeated if no vomiting after 30 min Integrity: mean time to emesis was 20 min (range 5‐50), 2 participants did not vomit until 50 min and 2 did not vomit at all Control arm: Type: no intervention Timing: NA Dose: NA Frequency: NA Integrity: NA |
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Outcomes |
Type (unit): Plasma paracetamol levels Adverse events Timing: prior to treatment and 60 min, 90 min and 150 min after the first sample (early) |
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Funding | No information | |
Notes | No treatment group was stopped for ethical reasons when the serum paracetamol levels increased between the first and last samples in 4 out of 5 participants. Data for gastric lavage was not extracted, because not within scope of this review. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information on randomization process |
Allocation concealment (selection bias) | Unclear risk | No information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants were not blinded (not possible due to difference in interventions); might influence outcomes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information on blinding, but should not affect outcome measurements |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No indication of incomplete outcomes |
Selective reporting (reporting bias) | High risk | No clinical outcomes reported, adverse events incompletely reported |
Other bias | Low risk | No other risk of bias detected |