| Methods |
Randomized, parallel group trial |
| Participants |
|
| Interventions |
Diclofenac 1 mg/kg intramuscularly at induction Papaveretum 0.2 mg/kg intramuscularly at induction |
| Outcomes |
Bleeding requiring surgical intervention Measured blood loss (subjective) Postoperative pain scores Postoperative nausea and vomiting |
| Notes |
Papaveretum now not commonly used for children. Intramuscular analgesia now considered inappropriate for children. 15 withdrawals mentioned in paper, unable to get in touch with author to account for these. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Trial numbers were randomized in blocks |
| Allocation concealment (selection bias) |
Low risk |
Randomization code was held by the hospital pharmacy |
| Baseline Imbalances
All outcomes |
Low risk |
Report on different surgical techniques but do not give information on male/female ratios |
| Blinding of participants and personnel (performance bias)
1. Perioperative bleeding requiring surgical intervention |
Low risk |
Syringes, identified only by the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Blinding of participants and personnel (performance bias)
2.Perioperative bleeding requiring non‐surgical intervention |
Low risk |
Syringes, identified only by the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Blinding of participants and personnel (performance bias)
3. Vomiting |
Low risk |
Syringes, identified only by the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Blinding of outcome assessment (detection bias)
1. Perioperative bleeding requiring surgical intervention |
Low risk |
Syringes, identified only by the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Blinding of outcome assessment (detection bias)
2. Perioperative bleeding requiring non‐surgical intervention |
Low risk |
Syringes, identified only be the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Blinding of outcome assessment (detection bias)
3. Vomiting |
Low risk |
Syringes, identified only be the patient's name were prepared by the pharmacy on day of operation. Therefore assumed all personnel blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Fifteen exclusions; five from diclofenac group and four from papaveretum group not given drugs because anaesthetist unaware of their participation in trial; one patient had obstructive sleep apnoea; five records lost or incomplete. Unable to account for withdrawals as unable to get in touch with the author |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias
All outcomes |
High risk |
Papaveretum given to more patients in intervention group. May affect vomiting results |
