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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 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.
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.
Interventions
- DRUG fentanyl
- DRUG dexmedetomidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2007-03 |
| Est. Completion | 2008-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00468052
The ClinicalTrials.gov registry entry for NCT00468052 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which fentanyl is the first listed.
NCT00468052 reports 0 study locations.
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.
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