Mehta 1997.
Methods | RCT | |
Participants | 28 participants with need for stem cell (bone marrow) transplantation (allograft or autologous), including those receiving TBI. Median age 8 years (range 4 to 12 years), 9/15 male in ondansetron group. Median age 9.5 years (range 4 to 17), 9/13 male in perphenazine group. | |
Interventions | 15 participants received ondansetron loading 0.15 mg/kg then 0.45 mg/kg as continuous infusion 13 participants received perphenazine 0.06 mg/kg loading and 0.4 mg/kg per 24 hours continuous infusion), plus diphenhydramine 1 mg/kg QDS |
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Outcomes | "Continuous" recording of vomiting and retching (events within 5 minutes considered as a single episode). Probably nursing staff recording outcomes | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) Acute nausea | High risk | Not reported |
Blinding (performance bias and detection bias) Acute vomiting | High risk | Not reported |
Blinding (performance bias and detection bias) Other outcomes | High risk | Blinding of care provider: no Blinding of participant: no Blinding of outcome assessors: no |
Incomplete outcome data (attrition bias) All outcomes | High risk | 3 not evaluated, unclear from which arm or even if excluded prior to randomisation |
Selective reporting (reporting bias) | Low risk | — |
Other bias | Low risk | No other risk of bias noted |