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. 2020 Apr 29;2020(4):CD011365. doi: 10.1002/14651858.CD011365.pub2

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:
  • Number randomised: 69 children (102 screened for eligibility, 12 did not meet inclusion criteria, 21 parents refused randomisation)

  • Number completed: 69 children


Participant (baseline) characteristics:
  • Age: 2 to 16 years

  • Gender: 52% males, 48% females


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
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
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