Methods |
Randomized, parallel group trial |
Participants |
|
Interventions |
Tenoxicam 0.75 mg/kg intramuscularly at induction
Morphine 0.2 mg/kg intramuscularly at induction
|
Outcomes |
Blood loss requiring surgical intervention
Pain (measured rescue analgesia)
Vomiting
|
Notes |
Study originally designed to look at pain. One withdrawal from morphine group included in our analysis so an ITT analysis could be performed. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Described as randomized but no further details given |
Allocation concealment (selection bias) |
Unclear risk |
Sealed envelopes used but no further details given |
Baseline Imbalances
All outcomes |
Unclear risk |
Demographic data comparable. But no details given of surgery type |
Blinding of participants and personnel (performance bias)
1. Perioperative bleeding requiring surgical intervention |
Unclear risk |
Unclear if surgeon blinded |
Blinding of participants and personnel (performance bias)
2.Perioperative bleeding requiring non‐surgical intervention |
Unclear risk |
N/a |
Blinding of participants and personnel (performance bias)
3. Vomiting |
Low risk |
Nursing staff blinded |
Blinding of outcome assessment (detection bias)
1. Perioperative bleeding requiring surgical intervention |
Unclear risk |
Unclear who is assessing patients |
Blinding of outcome assessment (detection bias)
2. Perioperative bleeding requiring non‐surgical intervention |
Unclear risk |
N/a |
Blinding of outcome assessment (detection bias)
3. Vomiting |
Low risk |
Nurses assessing patients were blinded |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Data for excluded child included in order to follow ITT principle |
Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
Other bias
All outcomes |
High risk |
Tenoxicam group required more morphine. Could affect vomiting results |