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

Pickering 2002.

Methods Randomized, parallel group trial
Participants
  • 103 children for elective tonsillectomy or


adenotonsillectomy
  • ASA I‐II

  • Age 3‐15 years (mean 7.0, 7.0)

  • Sex distribution: M/F (21/19, 7/11)

  • Country: UK

Interventions
  1. Rofecixib 0.625 mg/kg preoperatively

  2. Ibuprofen 5 mg/kg preoperatively

  3. Placebo preoperatively

Outcomes
  1. Need for early postoperative analgesia

  2. Interoperative blood loss

  3. Time to first postoperative analgesia

  4. Pain scores

  5. Analgesic consumption in the first 24hrs

  6. Vomiting and antiemetic use

  7. Incidence of primary and secondary haemorrhage

Notes Study had three groups. Data from the ibuprofen and placebo groups used in the review. Recruitment to placebo group finished early due to increased need for analgesics in this group.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated random number table
Allocation concealment (selection bias) Unclear risk Hospital pharmacist allocated children randomly to groups. But no further details on this
Baseline Imbalances 
 All outcomes Low risk Demographic details comparable and no large differences in surgery types between groups. However, recruitment to placebo group finished early
Blinding of participants and personnel (performance bias) 
 1. Perioperative bleeding requiring surgical intervention Unclear risk Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded
Blinding of participants and personnel (performance bias) 
 2.Perioperative bleeding requiring non‐surgical intervention Unclear risk Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded
Blinding of participants and personnel (performance bias) 
 3. Vomiting Unclear risk Patients and investigators blinded to group assignment. No mention of whether surgeon, anaesthetist or nurses blinded
Blinding of outcome assessment (detection bias) 
 1. Perioperative bleeding requiring surgical intervention Unclear risk Not clear who "investigators" are and whether they are assessing outcomes or not
Blinding of outcome assessment (detection bias) 
 2. Perioperative bleeding requiring non‐surgical intervention Unclear risk Not clear who "investigators" are and whether they are assessing outcomes or not
Blinding of outcome assessment (detection bias) 
 3. Vomiting Unclear risk Not clear who "investigators" are and whether they are assessing outcomes or not
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Three exclusions: one patient from placebo group given diclofenac during surgery; two patients from ibuprofen group ‐ one given diclofenac during surgery and one was too young. Small number of missing patients (5%) unlikely to affect results
Selective reporting (reporting bias) Low risk All expected outcomes reported
Other bias 
 All outcomes High risk Rescue analgesics used in both groups is same as intervention drug