Chang 2005.
Study characteristics | ||
Methods | Double‐blinded, parallel‐group randomised controlled surgical trial with 6 days of follow‐up | |
Participants |
Setting: Division of Pediatric Otolaryngology, Lucile Packard Children’s Hospital at Stanford and Department of Otolaryngology–Head Neck Surgery, Stanford University School of Medicine, USA Sample size:
Participant (baseline) characteristics:
Inclusion criteria: children scheduled to have tonsillectomy and adenoidectomy for obstructive sleep apnoea or sleep‐disordered breathing Exclusion criteria: history of recurrent or chronic tonsillitis or severe co‐morbidities |
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Interventions |
Intervention group: traditional tonsillectomy (TE) performed by electrocautery (n = 53 (n = 49 received surgery and were included in analyses)) Comparator group: intracapsular tonsillectomy (TT) using coblation (n = 75 (n = 52 received surgery and were included in analyses)) Use of additional interventions: concurrent adenoidectomy performed in 100% TE group and 98% TT group 35% of TE group and 29% of TT group received concurrent tympanostomy tube placement 2% of TE group received concurrent frenuloplasty and excision of tongue mucocele 2% of TT group received nasal endoscopy with cauterisation and concurrent direct laryngoscopy |
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Outcomes | Short‐term outcomes (6 days): mean peri‐operative blood loss, complications and readmissions, postoperative pain, type and frequency of pain medication, presence of nausea or vomiting, proportion of children with poor/fair/good oral intake, mean percentage of normal activity, parental days lost from work | |
Notes | Participants lost to follow‐up total: 21% (27 declined randomisation; 8% TE group versus 31% TT group) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Both the parents and the nurse practitioner performing the assessments were blinded to the treatment assignment." Surgeon not blinded to treatment assignment, unclear at what time the surgeon was notified of treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Both the parents and the nurse practitioner performing the assessments were blinded to the treatment assignment." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Significant number of randomised children (21%) not included in analyses; 4/53 (8%) declined to participate in tonsillectomy group versus 23/75 (31%) in tonsillotomy group |
Selective reporting (reporting bias) | Unclear risk | No protocol available; insufficient information to permit a judgement of low or high risk |
Other bias | Unclear risk | Baseline characteristics: balanced ITT analysis: unclear if performed Sample size calculations: performed Use of co‐interventions: balanced (concurrent adenoidectomy performed in 100%TE and 98% TT) |