Pickering 2002.
Methods | Randomized, parallel group trial | |
Participants |
adenotonsillectomy
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Interventions |
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Outcomes |
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Notes | Study had three groups. Data from the ibuprofen and placebo groups used in the review. Recruitment to placebo group finished early due to increased need for analgesics in this group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated random number table |
Allocation concealment (selection bias) | Unclear risk | Hospital pharmacist allocated children randomly to groups. But no further details on this |
Baseline Imbalances All outcomes | Low risk | Demographic details comparable and no large differences in surgery types between groups. However, recruitment to placebo group finished early |
Blinding of participants and personnel (performance bias) 1. Perioperative bleeding requiring surgical intervention | Unclear risk | Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded |
Blinding of participants and personnel (performance bias) 2.Perioperative bleeding requiring non‐surgical intervention | Unclear risk | Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded |
Blinding of participants and personnel (performance bias) 3. Vomiting | Unclear risk | Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded |
Blinding of outcome assessment (detection bias) 1. Perioperative bleeding requiring surgical intervention | Unclear risk | Not clear who "investigators" are and whether they are assessing outcomes or not |
Blinding of outcome assessment (detection bias) 2. Perioperative bleeding requiring non‐surgical intervention | Unclear risk | Not clear who "investigators" are and whether they are assessing outcomes or not |
Blinding of outcome assessment (detection bias) 3. Vomiting | Unclear risk | Not clear who "investigators" are and whether they are assessing outcomes or not |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Three exclusions: one patient from placebo group given diclofenac during surgery; two patients from ibuprofen group ‐ one given diclofenac during surgery and one was too young. Small number of missing patients (5%) unlikely to affect results |
Selective reporting (reporting bias) | Low risk | All expected outcomes reported |
Other bias All outcomes | High risk | Rescue analgesics used in both groups is same as intervention drug |