Status:
COMPLETED
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
Lead Sponsor:
University of Washington
Conditions:
Dental Caries in Children
Pediatric Dental Sedation
Eligibility:
All Genders
3-7 years
Phase:
PHASE4
Brief Summary
The primary objective of this randomized controlled trial is to assess the effects of oral sedation using midazolam and hydroxyzine with and without meperidine (a narcotic) on sedation outcomes in ped...
Detailed Description
Young children in the dental setting can pose significant behavioral challenges. These patients may have dental anxiety or lack the effortful control (self-regulation) to successfully navigate the den...
Eligibility Criteria
Inclusion
- Are between 36-95 months of age and are planned for dental treatment at the University of Washington Center for Pediatric Dentistry,
- Are ASA I or II, (healthy, or have mild, well-controlled systemic disease)
- Are under the 95th weight for age BMI (body mass index) percentile,
- Are able to take diagnostic bitewing dental radiographs,
- Are able to take medications by mouth,
- Have Brodsky scores of II or less (tonsil sizes take up less than 50% of the oropharyngeal opening at the back of the throat),
- Are planned to receive operative treatment under local anesthesia,
- Can understand and communicate with providers in English.
Exclusion
- Are diagnosed with autism, ADHD, or any other psychiatric or behavioral diagnosis,
- Are ASA III or higher (severe systemic disease),
- Are above the 95th weight for age BMI percentile,
- Are unable to take diagnostic radiographs,
- Will not tolerate taking medications by mouth,
- Have Brodsky scores of greater than II (tonsil sizes take up more than 50% of the oropharyngeal opening at the back of the throat),
- Have undergone oral sedation at a previous dental appointment,
- Cannot understand or communicate with providers in English.
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04068948
Start Date
June 25 2019
End Date
January 31 2023
Last Update
January 24 2024
Active Locations (1)
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1
University of Washington Center for Pediatric Dentistry
Seattle, Washington, United States, 98115