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 |
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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 |
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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 |
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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) |
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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.