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NCT01188551 · ClinicalTrials.gov registry record · Phase 2
Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement
A Phase 2 study of Chronic Otitis Media, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01188551: Completed Phase 2 study of Chronic Otitis Media, sponsored by Nationwide Children's Hospital.
NCT01188551 is a Phase 2 study of Chronic Otitis Media that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01188551, a Phase 2 study of Chronic Otitis Media, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
Primary Outcome
FLACC Behavioral Pain Assessment Scale: each of the five categories (F) Face, (L) Legs, (A) Activity, (C) Cry, (C) Consolability is scored from 0-2, which results in a total score between 0 and 10. 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort or pain or both
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
- DRUG Fentanyl
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-04 |
| Phase | Phase 2 |
What the finished NCT01188551 record still lists
NCT01188551 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Chronic Otitis Media appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT01188551 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT01188551 about?
NCT01188551 is a clinical study titled "Dexmedetomidine Versus Fentanyl Following Pressure Equalization Tube Placement". This is a study to compare intranasal dexmedetomidine to intranasal fentanyl following anesthesia induction in patients undergoing myringotomy and placement of pressure equalization (PE) tubes in providing analgesia and smoothing emergence from general anesthesia.
What is the current status of trial NCT01188551?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2011-01. Estimated completion is 2012-04.
What conditions does trial NCT01188551 study?
This clinical trial studies the following conditions: Chronic Otitis Media.
What interventions are being tested in trial NCT01188551?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG), Fentanyl (DRUG).
Who is sponsoring clinical trial NCT01188551?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01188551 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01188551's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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