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NCT00468052 · ClinicalTrials.gov registry record · Phase 3
Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
A Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT00468052: Completed Phase 3 study, sponsored by University of Medicine and Dentistry of New Jersey.
NCT00468052 is a Phase 3 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 122 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00468052, a Phase 3 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.
Primary Outcome
emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated . Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints
Interventions
- DRUG fentanyl
- DRUG dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
What the finished NCT00468052 record still lists
NCT00468052 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which fentanyl is the first listed.
NCT00468052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00468052 about?
NCT00468052 is a clinical study titled "Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy". Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known ...
What is the current status of trial NCT00468052?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2007-03. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00468052?
The interventions under investigation include: fentanyl (DRUG), dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT00468052?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00468052's enrollment target sits among peer trials
122 1617th of 2000 higher than 382 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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