Pond 1995.
Methods |
Study design: randomized controlled trial Study duration: recruitment period from 4 January 1988 to 11 June 1990 (29 months) Setting: hospital setting: emergency department of a tertiary referral hospital (Princess Alexandra Hospital, Brisbane) Country: Australia Number of individuals randomized: 876 Number of individuals receiving the intervention: 459 (ipecac or lavage) Ipecac: 220 Gastric lavage: 209 Number of individuals receiving the control: 417 (charcoal, oral or nasogastrically) AC: 274 Nasogastric tube: 133 Number of individuals lost to follow‐up: 82 Sample size calculated: post hoc power calculation |
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Participants |
Sex: 377 males and 499 females Age: male: 30 (SD 11; range 14‐82 years); female: 30 (SD 1; range 13‐81 years) Intervention: 30 (SD 12 years (range 13‐76 years) Control: 31 (SD 13 years; range 13‐82 years) Country (if different from study authors'): NA Type, dose and timing of poisoning: Participants presenting within 12 h of drug overdose (adsorbing to AC) whether accidental, intended or during recreational use, at the emergency department. Most presented earlier (140 < 1 h). 59% ingested more than 1 drug Ingestion of paracetamol, salicylate, phenothiazines or ethanol, or other drugs Inclusion criteria: history of drug overdose, whether accidental, intended or recreational, > 13 years old Exclusion criteria: ingestion > 12 h before presentation, treated in a way breaching the protocol, gastric emptying contraindicated, gastric emptying indicated for diagnostic purposes, substance not adsorbed by AC. Confirmation of intoxication by measuring in serum/blood |
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Interventions |
Intervention arm: Type: gastric emptying, being via ipecac in conscious and gastric lavage in obtunted participants. All participants received activated charcoal (Norit "C" Extra) in a slurry with 200 mL sorbitol. AC was given after ipecac‐induced vomiting had ceased or after gastric lavage Timing: before receiving AC‐sorbitol Dose: 30‐50 mL ipecac followed by 200 mL water; at least 2 L tap water for gastric lavage, via nasogastric tube Frequency: 1×, repeated if no vomiting within 30 min Integrity: no information Control arm: Type: activated charcoal‐sorbitol + supportive and drug‐specific treatment, orally in conscious and via nasogastric tube in obtunted participants Timing: after diagnosis and allocation to treatment group Dose: 50 g AC in 200 mL 70% sorbitol slurry Frequency: 1× Integrity: no information |
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Outcomes |
Type (unit): Proportion with clinical deterioration in the first 6 h after treatment Number of days hospitalized (for medical indication related to overdose or its treatment and complications) Number of complications Admission to ward/ICU Timing: clinical course was assessed over the first 6 h at 1‐2 h intervals (early) |
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Funding | No information | |
Notes | Data for gastric lavage was not extracted, because not within scope of this review | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Patients were allocated to one of two groups: those who presented on odd‐numbered dates to the emptied (E) group; those on even‐numbered days to the not‐emptied (NE) group." Comment: no adequate randomization |
Allocation concealment (selection bias) | High risk | Quote: "Patients were allocated to one of two groups: those who presented on odd‐numbered dates to the emptied (E) group; those on even‐numbered days to the not‐emptied (NE) group." Comment: allocation was not concealed, as randomisation scheme is predictable |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded (not possible due to difference in interventions); might influence outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding, but might affect assessment of subjective outcomes (clinical deterioration) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Not all participants allocated were treated, but the number remains small (9%) and reasons are thoroughly justified |
Selective reporting (reporting bias) | High risk | Certain outcomes (no. referred to wards/ICU, type of complication) only reported for gastric emptying group as a whole, not stratified per treatment |
Other bias | Low risk | No other risk of bias detected |