Phase 3
N=75
Intranasal Dexmedetomidine Premedication in Children
Preoperative Sedation
Bottom Line
View on ClinicalTrials.gov: NCT02250703 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: University of Michigan Sedation Scale — 15; 25; 22; 11 Participants — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Midazolam (Drug); Dexmedetomidine (Drug)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of Mississippi Medical Center
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY University of Michigan Sedation Scale |
15; 25; 22; 11; 12; 22 | 0.025 sig |
| SECONDARY Acceptance of Mask Induction |
35; 29; 2; 7 | >0.05 |
| SECONDARY Wake up Behavior |
37; 35; 0; 1 | >0.05 |
| SECONDARY Presence of Amnesia to Mask Induction |
6; 5; 24; 26 | >0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Children older than 5yrs and weighing more than 20kg , who are scheduled for ambulatory dental rehabilitation at Batson operating rooms.
- ASA classification 1 or 2
Exclusion Criteria
- Known allergy to midazolam, dexmedetomidine,morphine, fentanyl, sevoflurane and propofol.
- uncorrected congenital heart disease or history of cardiac arrhythmia,
- children at risk for airway obstruction (OSA or cranio facial syndrome),
- pregnant minors
Data sourced from ClinicalTrials.gov (NCT02250703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.