Chan 1987.
Methods | RCT Cross‐over |
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Participants | Any paediatric malignancy, but patients in whom a chemotherapy cycle was previously shown to cause moderate to severe drug‐induced nausea and vomiting No participants received cisplatin. Participants had not previously been treated with either nabilone or prochlorperazine. 30 participants, median age 11.8 years (3.5 to 17.8 years), gender not specified |
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Interventions | Nabilone orally (1 mg capsules) starting 8 to 12 hours prior to chemotherapy and repeated 2 or 3 times a day according to dosage schedule Original schedule: 18 to 27 kg 1 mg BD 27.1 to 36 kg 1 mg TDS > 36 kg 2 mg BD Modified schedule: < 18 kg 0.5 mg BD 18 to 30 kg 1 mg BD > 30 kg 1 mg TDS Prochlorperazine orally (capsules) starting 8 to 12 hours prior to chemotherapy and repeated 2 or 3 times a day according to dosage schedule Original schedule: 18 to 27 kg 5 mg BD 27.1 to 36 kg 5 mg TDS > 36 kg 10 mg BD Modified schedule: < 18 kg 2.5 mg BD 18 to 30 kg 5 mg BD > 30 kg 5 mg TDS |
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Outcomes | Vomiting was recorded as the total number of episodes of vomiting or retching | |
Notes | Study supported by a grant from Eli Lilly (company supplying nabilone) | |
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 | Unclear risk | Medical staff and participants/parents not aware of drug allocation, but nabilone has frequent, significant, and immediately identifiable side effects Blinding of care provider: unclear Blinding of participant: unclear Blinding of outcome assessors: unclear |
Blinding (performance bias and detection bias) Other outcomes | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 10 withdrawals, all included in toxicity assessments. 4 change of chemotherapy after cycle 1; 2 unable to cope with diagnosis and treatment; 2 received other antiemetics during study period; 2 cycle 2 of chemotherapy deferred because of severe dizziness/drowsiness after a single 2 mg dose of nabilone prior to treatment |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | No other risk of bias noted |