Passeron 1989.
Methods |
Study design: randomized controlled trial Study duration: no information on recruitment period, delay before presentation to the hospital was comparable between groups mean: intervention: 6.2 (SD 4.6); control: 7 (SD 4.6). Clinical follow‐up was done up to 48 h after administration/no administration of AC. Setting: hospital setting: emergency department of a university hospital Country: France Number of individuals randomized: 32 Number of individuals receiving the intervention: 16 Number of individuals receiving the control: 16 Number of individuals lost to follow‐up: 7 (44%) and 2 (13%) participants in control and intervention group did not have a blood sample at 9 h Sample size calculated: no information |
|
Participants |
Sex: no information on proportion of males and females Age: intervention: 36.6 (SD: 18.7) years control: 36.6 (SD: 14) years Country (if different from study authors'): NA Type, dose and timing of poisoning: Participants presenting at the emergency department with an overdose (confirmed by positive blood test) of benzodiazepines, barbiturates or imipramine. Participants in the intervention and control groups did not differ with regard to: their initial mean Glasgow Coma Scale score: intervention: 9 (SD 4.5); control: 10 (SD 4.5); drugs taken: intervention: 12 benzodiazepines, 2 barbiturates and 3 imipramine; control: 13 benzodiazepines, 1 barbiturates and 5 imipramine Inclusion criteria: overdose of benzodiazepines, barbiturates or imipramine. Confirmed blood toxicology test |
|
Interventions |
Intervention arm: Type: AC‐sorbitol, in addition to usual care (gastric lavage), delivered via nasogastric tube Timing: immediately after gastric lavage Dose: 1 g/kg AC in a 70% sorbitol solution Frequency: 1× Integrity: no information Control arm: Type: usual care, consisting of gastric lavage, forced diuresis and supportive treatment of symptoms Timing: NA Dose: NA Frequency: NA Integrity: NA |
|
Outcomes |
Type (unit): Glasgow Coma Scale Blood pressure Heart rhythm Serum levels of benzodiazepines, barbiturates and imipramine (µg/mL): evolution & proportion with increasing levels) (data not extracted) Side effects of the intervention: gastrointestinal issues, pulmonary complications, electrolyte balance (measured via ionogram, glycemia and acidosis) Timing: Glasgow Coma Scale: at 0 h, 3 h, 9 h, 24 h and 48 h after treatment (intermediate) Serum drug levels, blood pressure, heart rhythm, and side effects at 0 h, 3 h and 9 h after treatment (early) |
|
Funding | No information | |
Notes | — | |
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 | High risk | No information on blinding, but blinding not possible due to differences in treatments. May affect outcomes studied |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding, might influence assessment of outcomes, such as Glasgow Coma Scale |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Certain patients did not have a blood sample taken at 9 h." Comment: 7 (44%) and 2 (13%) patients in control and intervention group did not have a blood sample at 9 h |
Selective reporting (reporting bias) | High risk | Not reporting the normal pharmacokinetic outcomes, incomplete reporting of basically every outcome reported, no further reporting of the pre‐specified outcomes heart rhythm and pulse pressure |
Other bias | Low risk | No other risk of bias detected |