Mabro 2000.
Methods | RCT | |
Participants | Any patients with paediatric malignancy excluding cerebral tumours associated with vomiting Receiving moderately emetogenic chemotherapy:
OR highly emetogenic chemotherapy:
Patients were excluded if: received more than 1 course of chemotherapy in preceding year, radiation therapy in preceding 7 days or during course of study, emetogenic chemotherapy in preceding 7 days, persistent nausea or vomiting in preceding 48 hours, a food intolerance in preceding 4 days, intestinal obstruction, corticosteroids outside of chemotherapy treatment, other antiemetic treatments, cerebral tumours associated with vomiting, liver enzymes outside of specified range Mean age 7.8 years (range 1 year to 16 years). 177/294 participants were male |
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Interventions | 143 participants received 20 µg/kg oral granisetron (orange flavoured) ‐ diluted to 0.2 mg/ml and given 1 hour before and again 6 to 12 hours after the start of chemotherapy on each day of chemotherapy for 1 to 5 days (depending on chemotherapy regimen) 151 participants received 40 µg/kg oral granisetron (orange flavoured) ‐ diluted to 0.2 mg/ml and given 1 hour before and again 6 to 12 hours after the start of chemotherapy on each day of chemotherapy for 1 to 5 days (depending on chemotherapy regimen) |
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Outcomes | Number of vomits recorded every 6 hours for each 24‐hour period. Nausea assessed by unvalidated self/parent report using a scale of "none, mild, moderate, severe" | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | States "randomised" |
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 | Low risk | States "double blind" Blinding of care provider: yes Blinding of participant: yes Blinding of outcome assessors: yes |
Blinding (performance bias and detection bias) Other outcomes | Low risk | States "double blind" Blinding of care provider: yes Blinding of participant: yes Blinding of outcome assessors: yes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis reported by day |
Selective reporting (reporting bias) | Low risk | — |
Other bias | Low risk | Randomisation stratified by emetogenic level of chemotherapy |