Gaonkar 2004.
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: 36 hours |
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Participants | N = 50 Age: 4 to 72 months |
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Interventions | Group 1: (n = 25) extraoral infraorbital nerve block with 1 ml bupivacaine 0.25% plus adrenaline was administered and saline solution infiltration of the incision Group 2: (n = 25) saline solution was administered for nerve blockade, and 1 ml bupivacaine 0.25% plus adrenaline was infiltrated in the incision |
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Outcomes |
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Notes | Jadad score: 4 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double blinded. Saline solution used as control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double blinded. Saline solution used as control |
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 |