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. 2016 Apr 13;2016(4):CD011131. doi: 10.1002/14651858.CD011131.pub2

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
Participants N = 50
Age: 4 to 72 months
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
Outcomes
  • Postoperative pain relief scoring was measured according to Hanallah’s 10‐point score

  • Time to first analgesic given as a rescue

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