Komada 1999.
Methods | RCT Cross‐over |
|
Participants | Participants with ALL receiving either high‐dose methotrexate (3 g/m²) or high‐dose cytarabine plus dexamethasone (3 g/m²). Participants aged 6.3 years (range 1 year to 14 years), 21/49 male | |
Interventions | Granisetron 20 mcg/kg given immediately prior to chemotherapy at 30 min IV infusion Granisetron 40 mcg/kg given immediately prior to chemotherapy at 30 min IV infusion |
|
Outcomes | Episodes of vomiting recorded | |
Notes | 13 participants receiving Ara‐C had their treatment 'contaminated' by the concurrent use of dexamethasone as an antiemetic | |
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 | Blinding of care provider: no Blinding of participant: no Blinding of outcome assessors: no |
Blinding (performance bias and detection bias) Acute vomiting | High risk | Not reported |
Blinding (performance bias and detection bias) Other outcomes | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts in 24‐hour data, all completed cross‐over |
Selective reporting (reporting bias) | Low risk | Unclear if the HD‐MTX and high‐dose Ara‐C were identified a priori |
Other bias | High risk | Participants receiving Ara‐C had their treatment 'contaminated' by the concurrent use of dexamethasone |