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NCT02250703 · ClinicalTrials.gov registry record · Phase 3
Intranasal Dexmedetomidine Premedication in Children
A Phase 3 study of Preoperative Sedation, sponsored by University of Mississippi Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT02250703 is a Phase 3 study of Preoperative Sedation that has completed, run by University of Mississippi Medical Center. The registered enrollment target is 75 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02250703, a Phase 3 study of Preoperative Sedation, has completed, sponsored by University of Mississippi Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
BACKGROUND INFORMATION AND RATIONALE Pediatric patients scheduled for dental procedures under general anesthesia can have significant anxiety before the procedure. They are commonly pre medicated to minimize distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dose is more widely used for this purpose . However the commonly used maximum dose is up to 15mg. It also has many limitations such as paradoxical reaction, increased incidence of emergence delirium and negative postoperative behavior changes . Intranasal dexmedetomidine has been used an effective and safe alternative premedication to oral midazolam in children. At a dose of 2micrograms/kg, intranasal dexmedetomidine as premedication resulted in excellent sedation in children aged 5-8yrs with no adverse hemodynamic effects. It has other advantages such as providing analgesia and facilitating smooth emergence from anesthesia. The goal of this study is to find out if intranasal dexmedetomidine is a superior alternative as premedication to oral midazolam in children weighing more than 20kg undergoing general anesthesia for dental rehabilitation.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG Dexmedetomidine
Study Locations (1)
Mississippi
- Children's of Mississippi/University of Mississipi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02250703
The ClinicalTrials.gov registry entry for NCT02250703 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Mississippi Medical Center, which has 96 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Preoperative Sedation appearing as the primary indexed condition, and to 2 interventions - of which Midazolam is the first listed.
NCT02250703 reports 1 study location spanning 1 distinct geographic area - top geographies include Mississippi.
Frequently Asked Questions
What is clinical trial NCT02250703 about?
NCT02250703 is a clinical study titled "Intranasal Dexmedetomidine Premedication in Children". BACKGROUND INFORMATION AND RATIONALE Pediatric patients scheduled for dental procedures under general anesthesia can have significant anxiety before the procedure. They are commonly pre medicated to minimize distress and to facilitate a smooth induction of anesthesia. Oral Midazolam at 0.5mg/kg dos...
What is the current status of trial NCT02250703?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2014-09. Estimated completion is 2016-09.
What conditions does trial NCT02250703 study?
This clinical trial studies the following conditions: Preoperative Sedation.
What interventions are being tested in trial NCT02250703?
The interventions under investigation include: Midazolam (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT02250703?
This trial is sponsored by University of Mississippi Medical Center, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02250703 being conducted?
This trial has 1 study location across Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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