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

NCT03062488 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2020-01-18

Study results available
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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.

Conditions

  • Emergence Agitation
  • Pain

Interventions

DRUG

IV acetaminophen

multi-modal analgesia with IV acetaminophen

DRUG

Fentanyl

single modal analgesia

DRUG

PO acetaminophen

multi-modal analgesia with PO acetaminophen

Sponsors & Collaborators

  • University of Central Florida

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Carlos A Archilla, MD · Nemours Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2018-07-11
Completion
2018-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062488 on ClinicalTrials.gov