Hultén 1988.
Methods |
Study design: randomized controlled trial Study duration: no information Setting: hospital setting Country: Sweden Number of individuals randomized: 91 Number of individuals receiving the intervention: 34 Number of individuals receiving the control: 43 Number of individuals lost to follow‐up: 14 Sample size calculated: no information |
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Participants |
Sex: no information Age: older than 14 years Country (if different from study authors'): UK, Belgium, Sweden Type, dose and timing of poisoning: 32 participants took amitriptyline, 16 clomipramine, 10 mianserin, 9 imipramine, 6 dothiepin, 2 doxepin, 2 nortriptyline, mixed overdoses in 67% with most commonly benzodiazepines or alcohol Inclusion criteria: participants with self‐poisoning with 1 or more of 7 different TCA (mixed overdoses also included if clinician considered 1 of 7 TCA drugs was major cause of participants' symptoms) Exclusion criteria: participants < 14 years old, taken significant amount of other drugs Plasma TCA concentration < 0.3 µg/L |
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Interventions |
Intervention arm: Type: activated charcoal (MedicoalR) after gastric lavage Timing: no information Dose: 20 g Frequency: 1× Integrity: no information Control arm: Type: gastric lavage Timing: no information Dose: no information Frequency: 1× Integrity: no information |
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Outcomes |
Type (unit): AUC ((mg/L) × h) Blood pressure (mmHg) Heart rate (bpm) Coma grade (Matthew‐Lawson coma scale) Symptoms: e.g. convulsions, arrhythmias, muscle twitching Number of participants intubated Time spent intubated Time admitted to ICU (see Table 21) Time admitted to hospital (see Table 21) Timing: Plasma drug concentration at 0 h, 1 h, 2 h, 4 h, 8 h and 24 h (intermediate) Blood pressure, heart rate, coma grade and symptoms at 0 h, 4 h, 8 h and 24 h (intermediate) |
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Funding | No information | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by using rand numbers and equilibration made by groups of 10." Comment: adequate randomization |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was performed by using rand numbers and equilibration made by groups of 10." Comment: not enough information to make a judgement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information to support judgment, but lack of blinding may affect outcomes studied |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information to support judgment, but lack of blinding may affect outcomes studied |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "14 patients were excluded because they had taken a significant amount of other drugs" Comment: adequate explanation |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes have been reported |
Other bias | Low risk | No other risk of bias detected |