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NCT03062488 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Pain and Emergence Agitation, sponsored by Nemours Children's Clinic.

Completed
Registry status
Early Phase 1
Development phase
143
Enrollment target
1
Study location

NCT03062488 is a Early Phase 1 study of Pain and Emergence Agitation that has completed, run by Nemours Children's Clinic. The registered enrollment target is 143 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03062488, a Early Phase 1 study of Pain and Emergence Agitation, has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
Early Phase 1
Development phase
143 participants
Enrollment target
1
Study location

Study 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 Studied

Pain Emergence Agitation

Interventions

  • DRUG Fentanyl
  • DRUG IV acetaminophen
  • DRUG PO acetaminophen

Study Locations (1)

Florida

  • Nemours Children's Specialty Care - Jacksonville

Trial Details

FieldValue
Enrollment Target 143 participants
Start Date 2017-10-03
Est. Completion 2018-07-11
Phase Early Phase 1

Sponsor

Nemours Children's Clinic

108 total trials

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What the Registry Record Tells You About NCT03062488

The ClinicalTrials.gov registry entry for NCT03062488 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 143 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (53% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 3 interventions - of which Fentanyl is the first listed.

NCT03062488 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT03062488 about?

NCT03062488 is a clinical study titled "Emergence Agitation and Pain Scores in Pediatrics When Comparing Single-modal vs Multi-modal Analgesia for ENT Surgery". 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 an...

What is the current status of trial NCT03062488?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 143 participants. The study started on 2017-10-03. Estimated completion is 2018-07-11.

What conditions does trial NCT03062488 study?

This clinical trial studies the following conditions: Pain, Emergence Agitation.

What interventions are being tested in trial NCT03062488?

The interventions under investigation include: Fentanyl (DRUG), IV acetaminophen (DRUG), PO acetaminophen (DRUG).

Who is sponsoring clinical trial NCT03062488?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03062488 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.