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NCT00678379 · ClinicalTrials.gov registry record · Phase 3
Pediatric Tonsillectomy Pain Reduction Study
A Phase 3 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
NCT00678379 is a Phase 3 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 120 participants.
The verdict
NCT00678379, a Phase 3 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
Study Summary
Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration of the tonsillar fossa comparing three treatment regimens in reducing post-tonsillectomy morbidity (i.e. pain, poor oral intake): 1) Placebo (saline injection) 2) bupivacaine (0.5%) + lidocaine (1%), 3) bupivacaine (0.5%) + lidocaine (1%) + clonidine (25 µg).
Interventions
- DRUG Normal saline
- DRUG lidocaine (1%) + bupivacaine (0.5%)
- DRUG Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678379
The ClinicalTrials.gov registry entry for NCT00678379 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Normal saline is the first listed.
NCT00678379 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678379 about?
NCT00678379 is a clinical study titled "Pediatric Tonsillectomy Pain Reduction Study". Tonsillectomy is associated with a significant decrease quality of life in children secondary to pain, which is worsened with swallowing. The objective of the current study is to conduct a prospective, double-blind, placebo-controlled, randomized clinical trial using a pre-tonsillectomy infiltration...
What is the current status of trial NCT00678379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2008-04. Estimated completion is 2009-11.
What interventions are being tested in trial NCT00678379?
The interventions under investigation include: Normal saline (DRUG), lidocaine (1%) + bupivacaine (0.5%) (DRUG), Lidocaine (1%) + Bupivacaine (0.5%) + Clonidine (25mcg) (DRUG).
Who is sponsoring clinical trial NCT00678379?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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