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

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
  • Pain: measured by Children and Infants Postoperative Pain Scale score

  • Supplemental analgesic requirements

  • Length of analgesia

  • Time to feed

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