Chang 2008.
Study characteristics | ||
Methods | Double‐blinded, parallel‐group randomised controlled trial with 6‐day duration of follow‐up | |
Participants |
Setting: single paediatric otolaryngology clinic, Stanford, California, USA Sample size:
Participant (baseline) characteristics:
Inclusion criteria: scheduled for tonsillectomy and adenoidectomy for OSA/SDB; no further diagnostic criteria provided Exclusion criteria: significant comorbidities, significant history of recurrent/chronic tonsillitis |
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Interventions |
Intervention group: tonsillectomy (TE) using coblation (n = 35) Comparator group: tonsillotomy (TT) using coblation (n = 34) Use of additional interventions: curette adenoidectomy – proportion unclear |
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Outcomes | Short‐term outcomes (6 days): postoperative pain (child and parent perception), analgesia use, presence of nausea/vomiting, return to normal diet, return to normal activity, days of missed work for parents and complications or readmissions | |
Notes | Participants lost to follow‐up total: 0% | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned to treatment groups" – no method given |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both the parents and the nurse practitioner who performed the assessments were blinded" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Both the parents and the nurse practitioner who performed the assessments were blinded" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No statement of dropouts |
Selective reporting (reporting bias) | High risk | Two outcomes not reported (analgesia required, days parents required off work) |
Other bias | Unclear risk | Baseline characteristics: balanced ITT analysis: performed Formal sample size calculations: performed Use of co‐interventions: not stated across groups |