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. 2018 Dec 19;2018(12):CD013230. doi: 10.1002/14651858.CD013230

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
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
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
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)
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