Study characteristics |
Methods |
Belgian, multicenter, prospective, double‐blind, placebo‐controlled, parallel assignment, randomized phase III trial in high‐risk breast cancer patients |
Participants |
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Interventions |
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Outcomes |
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Notes |
Funded by the Anticancer Fund, the Belgian Society of Anaesthesia and Resuscitation, the Foundation Saint‐Luc; the Commission du Patrimoine of the Université catholique de Louvan, St‐Luc Hospital |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomized controlled trial. Randomization of eligible patients was done the day before surgery and used randomisation blocks of 4. There was no stratification factor. |
Allocation concealment (selection bias) |
Low risk |
In each center, a randomisation list was kept
accessible exclusively to the pharmacist in charge of the preparation of the study product (ketorolac or placebo). For each patient, a sealed opaque envelope was provided. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Patients were given one dose of intervention or a matching
placebo. Each patient was randomly assigned on a 1:1 ratio to receive either 30 mg of ketorolac or a placebo during the induction of anesthesia (pre‐incision). The placebo consisted of NaCl 0.9% (3 mL) and was identically presented to ensure double‐blinding. No dose modification was allowed because only one single dose was administered. |
Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
A randomisation list was kept accessible exclusively to the pharmacist in charge of the preparation of the study product. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
1 patient with missing data in placebo group for postoperative pain intensity within 24 (± 12) hours of surgery |
Selective reporting (reporting bias) |
Low risk |
Trial registration confirmed all reported outcomes were assessed |