Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
Condition: Dental Caries in Children; Pediatric Dental Sedation; Meperidine; Hydroxyzine; Midazolam
MeSH terms: Dental Caries
Intervention: Meperidine; Hydroxyzine; Midazolam
Intervention description: This intervention assesses a child's behavioral outcome for dental procedural sedation in combination with midazolam and hydroxyzine. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.; This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.; This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
Intervention MeSH terms: Midazolam; Meperidine; Hydroxyzine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized clinical trial where participants are assigned randomly to receive a sedation regimen of either midazolam+hydroxyzine+meperidine or midazolam+hydroxyzine.
Masking: Single (Participant)
Masking description: The participant is unaware of the regimen given. The care provider and investigator(s) are aware of the regimen given.
Enrollment: 37.0
Sex: All
Minimum age: 3 Years
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility 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.