Parker 2001.
Methods | RCT Cross‐over | |
Participants | Participants with ALL receiving intrathecal chemotherapy +/‐ maintenance chemotherapy. Median age 6 years (range 2 to 17 years). 12/26 were male | |
Interventions | High‐dose ondansetron 0.45 mg/kg IV 15‐minute infusion 30 minutes prior to lumbar puncture Low‐dose ondansetron 0.15 mg/kg IV 15‐minute infusion 30 minutes prior to lumbar puncture Placebo (saline) IV 15‐minute infusion 30 minutes prior to lumbar puncture |
|
Outcomes | Parental report of number of vomiting episodes recorded | |
Notes | Given the low potential of chemotherapy itself, seems more like a trial of post‐anaesthetic antiemetics than of chemotherapy‐induced emesis | |
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 | Low risk | States double‐blind. No further details. Blinding of care provider: yes Blinding of participant: yes Blinding of outcome assessors: yes |
Blinding (performance bias and detection bias) Other outcomes | High risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts between cross‐overs (1 before placebo, 2 before ondansetron 0.45 mg/kg) |
Selective reporting (reporting bias) | Low risk | — |
Other bias | Low risk | No other risk of bias noted |