Rajamani 2007.
Study characteristics | ||
Methods |
Study design: prospective, randomised, double‐blind, controlled trial Intention‐to‐treat: Not stated Sample size calculation: Not stated Setting: single centre. India Follow up: 2 hours |
|
Participants | N = 82 (60.9% male) Age: 3 months to 10 years |
|
Interventions | Group 1: (n = 41) extraoral infraorbital nerve block with 2 ml of bupivacaine 0.25% was administered and intravenous saline solution instead of intravenous analgesia Group 2: (n = 41) saline solution was administered for nerve blockade, instead of bupivacaine, and intravenous fentanyl (2 µg/kg) was provided |
|
Outcomes |
|
|
Notes | Jadad score: 5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The author informed us by email that randomisation was by drawing lots from a box including folded papers with the 2 anaesthetic options being pre‐written |
Allocation concealment (selection bias) | Low risk | The author informed us by email that randomisation was by drawing lots from a box including folded papers with the 2 anaesthetic options being pre‐written |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "anaesthesiologist (blinded to the analgesic used) assessed the child’s airway reflexes, recovery from anaesthesia, respiratory and cardiovascular status and operative site bleeding" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "child was handed over to the mother, and was monitored by the recovery room nurse. The nurse was blinded to the analgesia used" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses |
Selective reporting (reporting bias) | Low risk | The report of the study was free of suggestion of selective outcome reporting |
Other bias | High risk | Size: sample size less than 50 per treatment arm |