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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: Completed Early Phase 1 study of Pain and Emergence Agitation, sponsored by Nemours Children's Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Post Anesthesia Emergence Delirium (PAED) Scale 0 - 20. EA defined as a score equal or greater than 12
Conditions Studied
Interventions
- DRUG Fentanyl
- DRUG IV acetaminophen
- DRUG PO acetaminophen
Study Locations (1)
Florida
- Nemours Children's Specialty Care - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2017-10-03 |
| Est. Completion | 2018-07-11 |
| Phase | Early Phase 1 |
What the finished NCT03062488 record still lists
NCT03062488 is an interventional study that assigns participants to a tested intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03062488's enrollment target sits among peer trials
143 121st of 374 higher than 254 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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