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. 2016 Feb 2;2016(2):CD007786. doi: 10.1002/14651858.CD007786.pub3

Mabro 2000.

Methods RCT
Participants Any patients with paediatric malignancy excluding cerebral tumours associated with vomiting
Receiving moderately emetogenic chemotherapy:
  • carboplatin (>= 500 mg/m²)

  • cyclophosphamide (>= 500 to 900 mg/m²) in combination with other agents

  • ifosfamide (1 to 2.4 g/m²)

  • actinomycin D (>= 1.5 mg/m²)

  • cisplatin (20 to 49 mg/m²)

  • methotrexate (> 8 g/m²)

  • adriamycin (>= 60 mg/m²)

  • cytarabine (1 to 2.9 g/m²)


OR highly emetogenic chemotherapy:
  • cyclophosphamide (>= 1000 mg/m²)

  • cisplatin (>= 50 mg/m²)

  • ifosfamide (>= 2.5 g/m²)

  • nitrogen mustard (> 6 mg/m²)

  • dacarbazine (> 200 mg/m²)

  • cytarabine (>= 3 g/m²)


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
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)
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