Park 2007.
Study characteristics | ||
Methods | Double‐blinded, parallel‐group randomised controlled surgical trial with 1‐week duration of follow‐up | |
Participants |
Setting: university paediatric children's hospital, Utah, USA Sample size:
Participant (baseline) characteristics:
Inclusion criteria: children undergoing adenotonsillectomy for airway obstruction or difficulty breathing who are otherwise healthy Exclusion criteria: patients with diabetes, cardiac conduction abnormalities, electrolyte abnormalities, liver or kidney insufficiency, hypersensitivity to acetaminophen or hydrocodone, history of chronic pain, pregnancy, patients with chronic tonsillitis |
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Interventions |
Intervention group: total tonsillectomy (TE) with monopolar cautery (n = 21) Comparator group: subtotal tonsillectomy (TT) with bipolar cautery (n = 19) Use of additional interventions: adenoidectomy in 100% of participants |
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Outcomes | Short‐term outcomes (1 week): postoperative pain at rest and while eating, intraoperative blood loss, return to normal activity, oral intake, neck, ear and throat pain scales, number of episodes retching and emesis, frequency and analgesic use and rescue medication, presence of fever, time to take 100 cm3 of fluid, quantity of liquids consumed, complications or calls to the physician | |
Notes |
Participants lost to short‐term follow‐up total: 0% Participants lost to long‐term follow‐up total: 3% (5% TE, 0% TT) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A computer generated number table guided the randomization of the patients to receive either a subtotal tonsillectomy or total removal of the tonsils" |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐blinded clinical trial"; no further details given |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "double‐blinded clinical trial"; no further details given |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 1 patient lost to long‐term follow‐up |
Selective reporting (reporting bias) | Unclear risk | Analgesic use not reported |
Other bias | Unclear risk | Baseline characteristics: not balanced for gender in TT group (26% M:74% F) ITT analysis: performed Formal sample size calculations: not performed Use of co‐interventions: balanced across groups (adenoidectomy performed in 100% TE group and 100% TT group) |