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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: Completed Phase 3 study of Preoperative Sedation, sponsored by University of Mississippi Medical Center.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Level of sedation at separation from parents and at the time of mask induction will be measured on a scale of 0 to 4 (University of Michigan Sedation Scale) University of Michigan Sedation Scale: 0 -Awake/Alert 1 -Minimally Sedated: Tired/sleepy, appropriate response to verbal conversation and/or sounds. 2- Moderately Sedated: Somnolent/sleeping, easily aroused with light tactile stimulation. 3 - Deeply Sedated: Deep sleep, arousable only with significant physical stimulation. 4 - Unarousa
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 |
What the finished NCT02250703 record still lists
NCT02250703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02250703's enrollment target sits among peer trials
75 1773rd of 2000 higher than 221 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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