| Methods |
Randomized, parallel group trial |
| Participants |
65 children for elective tonsillectomy or adentonsillectomy ASA I ‐ II Age: 4 ‐ 16 years (mean 7.4 ± 3.2, 7.3 ± 3.3) Sex distribution: M/F (15/15, 15/17) Country: UK |
| Interventions |
Fentanyl 1–2 μg/kg intravenously, Diclofenac 1–2 mg/kg rectally during surgery. Codeine 1.5mg/kg intramuscularly during surgery. |
| Outcomes |
Incidence of postoperative vomiting and nausea Time to first postoperative analgesia Maximum pain scores Fitness for discharge at 4 hrs Primary or secondary haemorrhage |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated random list |
| Allocation concealment (selection bias) |
Unclear risk |
Numbered envelopes. Does not give further details |
| Baseline Imbalances
All outcomes |
Low risk |
Similar number of tonsillectomies and adenotonsillectomies |
| Blinding of participants and personnel (performance bias)
1. Perioperative bleeding requiring surgical intervention |
Unclear risk |
Not clear if surgical team/nursing staff were blinded |
| Blinding of participants and personnel (performance bias)
2.Perioperative bleeding requiring non‐surgical intervention |
Unclear risk |
Not clear if surgical team/nursing staff were blinded |
| Blinding of participants and personnel (performance bias)
3. Vomiting |
Unclear risk |
Not clear if surgical team/nursing staff were blinded |
| Blinding of outcome assessment (detection bias)
1. Perioperative bleeding requiring surgical intervention |
Low risk |
Investigator blinded to allocation made all postoperative observations |
| Blinding of outcome assessment (detection bias)
2. Perioperative bleeding requiring non‐surgical intervention |
Low risk |
Investigator blinded to allocation made all postoperative observations |
| Blinding of outcome assessment (detection bias)
3. Vomiting |
Low risk |
Investigator blinded to allocation made all postoperative observations |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Three missing patients: two due to protocol violations and one due to cancellation of surgery. Not clear if randomized. Small number of missing patients (<10%) unlikely to affect results |
| Selective reporting (reporting bias) |
Low risk |
All outcomes reported |
| Other bias
All outcomes |
High risk |
Codeine group received ibuprofen postoperatively, Ibuprofen group received fentanyl |
