At a glance
ClinicalIndex Comparison Record- ✓Age 24 months through 7 years
- ✓Weight less than 50 kg
- ✓Able to take medications by mouth (PO)
- ✓ASA Classification I or II (low surgical risk)
- ✕History of developmental delay or psychological disorders increasing emergence agitation risk
- ✕Previous hypersensitivity to acetaminophen, fentanyl, or placebo components
- ✕Severe hepatic impairment or active hepatic disease
- ✕Prior malignant hyperthermia or susceptibility to volatile anesthetics
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Emergence Agitation and Pain Scores in Pediatric Patients Following Sevoflurane Anesthesia When Comparing Single-modal Versus Multi-modal Analgesia for Routine Ear-nose-throat (ENT) Surgery, a Multi-center Double-blinded Study
In Brief
A Early Phase 1 clinical trial evaluating IV acetaminophen, Fentanyl, and 1 other intervention for Emergence Agitation and Pain. Completed, enrolled 143 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
multi-modal analgesia with IV acetaminophen
single modal analgesia
multi-modal analgesia with PO acetaminophen