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. 2013 Jul 18;2013(7):CD003591. doi: 10.1002/14651858.CD003591.pub3

St Charles 1997.

Methods Randomized, parallel group trial
Participants
  • 110 children undergoing tonsillectomy with or without other procedures

  • ASA status not stated

  • Age 16‐168 months (mean 77, 67)

  • Sex distribution: M/F (3.2, 3.2)

  • Country: USA

Interventions
  1. Ibuprofen 5 mg/kg orally postoperation

  2. Paracetamol up to 15 mg/kg and codeine 1 mg/kg orally postoperation

Outcomes
  1. Bleeding requiring surgical intervention

  2. Bleeding requiring nonsurgical treatment

  3. Mild postoperative bleeding

  4. Pain (mild or moderate or severe)

  5. Nausea and emesis

Notes Surgical technique included electro‐dissection or cold dissection and snare techniques.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomly assigned to one of two groups. No details given
Allocation concealment (selection bias) Unclear risk No details given.
Baseline Imbalances 
 All outcomes Low risk Lots of surgical techniques but balanced. Demographic data clearly reported and largely equivalent
Blinding of participants and personnel (performance bias) 
 1. Perioperative bleeding requiring surgical intervention High risk Assumed no‐one blinded
Blinding of participants and personnel (performance bias) 
 2.Perioperative bleeding requiring non‐surgical intervention High risk Assumed no‐one blinded
Blinding of participants and personnel (performance bias) 
 3. Vomiting High risk Assumed no‐one blinded
Blinding of outcome assessment (detection bias) 
 1. Perioperative bleeding requiring surgical intervention High risk Inconsistencies in how data collected (some retrospectively from charts). No blinding. Not clear how bleeding detected. Parents in intervention group given free samples to take home
Blinding of outcome assessment (detection bias) 
 2. Perioperative bleeding requiring non‐surgical intervention High risk Inconsistencies in how data collected (some retrospectively from charts). No blinding. Not clear how bleeding detected. Parents in intervention group given free samples to take home
Blinding of outcome assessment (detection bias) 
 3. Vomiting High risk Nurses and parents not blinded ‐ responsible for reporting and recording any signs of PONV
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No incomplete data
Selective reporting (reporting bias) Low risk All expected outcome measures reported
Other bias 
 All outcomes High risk Extra analgesics given in OR and during observation period. May affect vomiting outcomes. Inconsistencies mean that treatment was barely standardized