Behnoush 2009.
Methods |
Study design: randomized controlled trial Study duration: July 2003 to September 2004 Setting: hospital setting (poisoning ward of the Loghman Hospital, Tehran) Country: Iran Number of individuals randomized: 68 Number of individuals receiving the intervention: 38 Number of individuals receiving the control: 30 Number of individuals lost to follow‐up: unclear, as loss to follow‐up was considered an exclusion criterion for the study Sample size calculated: yes, but methods are not clearly reported: "The sample size was measured according to the descriptive studies formula, and the P value was calculated based on the number of controls with carbamazepine poisoning in Loghman Hospital, in previous years." |
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Participants |
Sex: 28 males and 40 females Age: 24.2 years, range 13‐65 years Country (if different from study authors'): NA Type, dose and timing of poisoning: Participants admitted to the poisoning ward with history of carbamazepine poisoning: Dose average (range): 6.8 g (1.2‐24 g) Delay between drug intake and admission average (range): 7.44 h (0.5 h to 15 h) Inclusion criteria: poisoning confirmed by clinical examination and paraclinical tests Exclusion criteria: taken other drugs or unknown drugs, hospitalization not needed, left hospital before completion of treatment, not possible to confirm poisoning by carbamazepine |
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Interventions |
Intervention arm: Type: MDAC via nasogastric tube + supportive treatment (including gastric lavage) Timing: every 4 h Dose: 100 g AC per dose Frequency: several, but unknown number of doses Integrity: no information Control arm: Type: SDAC via nasogastric tube + supportive treatment (including gastric lavage) Timing: no information provided, presumably after poisoning confirmation Dose: not specified, but likely 100 g AC Frequency: 1× Integrity: no information |
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Outcomes |
Type (unit): duration of hospitalization (h) (see Table 21) Timing: no information |
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Funding | No information | |
Notes | All 8 ICU participants, with grade III or IV level of unconsciousness received the multi‐dose treatment, thus seem not to have been randomized and were therefore not included in the analysis of hospitalization duration | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "In all patients admitted to I.C.U. and 30 patients of the ward, multiple doses of charcoal were administered, whereas the resting 30 patients ‐who were chosen randomly‐ received single doses of charcoal" Comment: not enough information to make a judgment |
Allocation concealment (selection bias) | Unclear risk | Quote: "In all patients admitted to I.C.U. and 30 patients of the ward, multiple doses of charcoal were administered, whereas the resting 30 patients ‐who were chosen randomly‐ received single doses of charcoal" Comment: not enough information to make a judgment |
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 | Unclear risk | Quote: "The following patients were excluded from the study: those who left the hospital before the treatment process was completed" Comment: participants that did not complete the treatment process were excluded and no data is available on the number of people |
Selective reporting (reporting bias) | High risk | Occurrence of complications not clearly described: unclear in which group they occurred. Drug and symptom monitoring are crucial outcomes that are lacking in this study. Especially for symptom monitoring, which was described as being the criterion for hospital discharge, this is problematic. |
Other bias | Low risk | No other risk of bias detected |