Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years

• Status: Active, not recruiting
• Trial end date: 2022-06-20
• Target enrollment: 0
• Participant gender: All

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 pediatric dental patients undergoing dental treatment at the University of Washington Center for Pediatric Dentistry. Procedural sedation can be offered as an option for dental treatment for a young, potentially uncooperative pediatric patient to safely and effectively complete dental restorative needs. Both sedation regimens are already regularly used for patients at the UW CPD. The goal of this study is to assess if removing a narcotic from the regimen will produce the same behavioral success outcomes as a regimen with a narcotic. Our hypothesis is that patients who receive oral sedation using midazolam, hydroxyzine, and meperidine will experience fewer behavioral failures than those who receive oral sedation using midazolam and hydroxyzine without meperidine.

The secondary objective of this project is to evaluate the relationship between child temperament and sedation outcome in each treatment group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Hydroxyzine; Meperidine; Midazolam

Criteria

Inclusion Criteria:

1. Are between 36-95 months of age and are planned for dental treatment at the University of Washington Center for Pediatric Dentistry,

2. Are ASA I or II, (healthy, or have mild, well-controlled systemic disease)

3. Are under the 95th weight for age BMI (body mass index) percentile,

4. Are able to take diagnostic bitewing dental radiographs,

5. Are able to take medications by mouth,

6. Have Brodsky scores of II or less (tonsil sizes take up less than 50% of the oropharyngeal opening at the back of the throat),

7. Are planned to receive operative treatment under local anesthesia,

8. Can understand and communicate with providers in English.

Exclusion Criteria:

1. Are diagnosed with autism, ADHD, or any other psychiatric or behavioral diagnosis,

2. Are ASA III or higher (severe systemic disease),

3. Are above the 95th weight for age BMI percentile,

4. Are unable to take diagnostic radiographs,

5. Will not tolerate taking medications by mouth,

6. Have Brodsky scores of greater than II (tonsil sizes take up more than 50% of the oropharyngeal opening at the back of the throat),

7. Have undergone oral sedation at a previous dental appointment,

8. Cannot understand or communicate with providers in English.