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

Wax 1999.

Methods Study design: randomized controlled trial
Study duration: 27‐month recruitment period
Setting: home setting, with telephone support from a poison centre
Country: USA
Number of individuals randomized: 103
Number of individuals receiving the intervention: 51
Number of individuals receiving the control: 52
Number of individuals lost to follow‐up: 0
Sample size calculated: no information
Participants Sex: 57 male and 46 female
Age: median (range): 2 years (9 months‐5 years)
Country (if different from study authors'): NA
Type, dose and timing of poisoning: asymptomatic participants with suspected ingestion of a small number (< 6) of potentially toxic berries, including Taxus species (yew), Solanum americanus (nightshade), Ilex species (holly) or unknown berries
Exclusion criteria: ingestion of a known other type of berry, > 5 berries ingested, symptomatic when calling poison centre, parents planning transport to healthcare facility regardless of the advice of the poison centre, ingestion of more than 1 type of berry/plant parts, contraindication for syrup of ipecac
Interventions Intervention arm:
Type: syrup of ipecac (+ home observation)
Timing: no information
Dose: no information
Frequency: no information
Integrity: no information
Control arm:
Type: home observation
Timing: NA
Dose: NA
Frequency: NA
Integrity: NA
Outcomes Type (unit): symptom assessment (vomiting, diarrhoea, abdominal pain, drowsiness, agitation) and disposition assessment (ED referral, hospital admission)
Timing: 24 h after telephone call to poison centre (intermediate)
Funding No information
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "The group who called the poison centre on even days of the month received ipecac followed by parenteral/guardian HO. The group that called the poison centre on odd days of the month were assigned to the HO only group"
Comment: not an adequate method of randomization
Allocation concealment (selection bias) High risk Randomization method does not allow for allocation concealment.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not possible to blind, but might affect subjective symptom outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Outcome assessors were not blinded, which might influence assessment of subjective symptom outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No indication of missing data
Selective reporting (reporting bias) Low risk Specified outcomes are reported
Other bias High risk Only asymptomatic participants included, no confirmation of actual ingestion and uptake, reporting dichotomous outcomes while measuring using an ordinal scale

AC: activated charcoal; APACHE: acute physiology and chronic health evaluation; AUC: area under the receiver operating curve; bpm: beats per minute; CBZ: carbamazepine; ECG: electrocardiogram;ED: emergency department; ICU: intensive care unit; IQR: interquartile range; MDAC: multi‐dose activated charcoal; NA: not applicable; SAPS: simplified acute physiology score; SD: standard deviation; SDAC: single‐dose activated charcoal; SEM: standard error of the mean; SOI: syrup of ipecac; TCA: tricyclic antidepressant; UC: University of California.