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

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:
  • Number randomised: 40 children

  • Number completed: 39 children


Participant (baseline) characteristics:
  • Age: 2 to 12 years

  • Gender: 35% males, 65% females


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
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
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)
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)