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

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
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
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
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)
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