Ekert 1979.
| Methods | RCT Multiple randomisations per participant, each independent |
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| Participants | Any paediatric malignancy. Age and gender not recorded. Any regimen of chemotherapy, with mixed emetogenicity. No platinums. Courses included: high‐dose methotrexate (7.5 g/m²) = 6, lower‐dose vincristine (.625 g/m²) = 5, doxorubicin (60) = 2, vincristine‐doxorubicin‐dacarbazine = 7, vincristine‐prednisolone‐cyclophosphamide‐doxorubicin = 4, cytosine‐cyclophosphamide‐asparaginase = 6, cytarabine/6Thioguanine = 3, 5FU‐doxorubicin‐actinomycinD = 2, lomustine‐vincristine = 7 |
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| Interventions | Tetrahydrocannabinol 10 mg/m², given at ‐2, 4, 8, 16, and 24 hours around chemotherapy administration Metoclopramide 5 mg (for < 0.7 m² participants) or 10 mg (for > 0.7 m² participants) at ‐2, 8, 16, and 24 hours. Placebo given at +4 hours |
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| Outcomes | Nurse recorded outcomes (as inpatient) or parent/child recorded diary. Vomiting episodes and nausea (present/absent) reported | |
| Notes | First of 2 randomisations, second reported as Ekert 1979a | |
| 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 | Unclear risk | Stated "double blinded", but cannabinoids have 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) Acute vomiting | Unclear risk | Stated "double blinded", but cannabinoids have 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 | Full report of data |
| Selective reporting (reporting bias) | Low risk | — |
| Other bias | Unclear risk | Stopped early because of failure of efficacy of metoclopramide (7 courses of tetrahydrocannabinol "missed") |