drugset / Trial / NCT03062488

Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery

NCT03062488

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to compare the incidence of EA in pediatric patients undergoing minor ENT surgery under Sevoflurane and compare opioid-only based intra-operative analgesia to multi-modal analgesia consisting of opioid and IV acetaminophen or PO acetaminophen regimen using a validated and standardized EA measurement tool, the Pediatric Anesthesia Emergence Delirium (PAED) scale. The post operative pain scores will be measured in all patients by post-op recovery staff using FLACC Score/Wong-Baker FACES (patients 24 months up to 7 years of age) or Numeric Pain Score for patients 7 years of age. The pre-operative, surgery, anesthesia and post-operative staff will be all blinded.

Timeline

Start
2017-10-03
Primary completion
2018-07-11
Completion
2018-07-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 15 mg/kg Intravenous
Comparator Fentanyl Other / unclassified 2 ug/kg Intravenous

Indications

No indication recorded.