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
Study type: Interventional
Phase: Phase 4

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.
    

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 dental experience. Oral procedural sedation is an advanced
      pharmacological behavior guidance technique that can be used as part of the pediatric
      dentist's armamentarium when basic behavior guidance techniques are likely to be ineffective.
      Oral sedation can be a valuable tool, not only to facilitate dental treatment, but also to
      protect a young child's psyche, reduce dental fear, and ensure safety of both the patient and
      the dental team.

      Case selection is crucial to optimizing sedation outcomes. In addition to biological factors
      like age, gender, and weight, temperament must also be carefully evaluated for the pediatric
      oral sedation candidate. Compared with children with high levels of effortful control,
      children who exhibit high levels of impulsivity may be more likely to respond poorly to
      uncomfortable or unfamiliar procedures, exhibit uncooperative behavior during sedation, and
      ultimately experience more sedation failures.

      There is no standard drug regimen or protocol for oral sedation. Medications used for
      sedation studies often have a wide therapeutic range, and dosages used in the literature vary
      widely. Varying drug regimens can also be used depending on operator preference and the
      extent of the procedure. Benzodiazepines, opioids, and antihistamines are commonly used drug
      options that can be used alone or in combination to achieve desired sedative effects and
      minimize potential side effects of counterpart drugs. For example, midazolam is a
      rapid-onset, short acting benzodiazepine that offers a sedative effect with some degree of
      amnesia. These qualities make midazolam an ideal sedative for relatively minor or quick
      operative procedures in young children. An opioid such as meperidine can be added to
      potentiate the sedative effect and offer analgesia for lengthier, more complex procedures.
      Additionally, an antihistamine like hydroxyzine can be added for additional sedative effects
      as well as an antiemetic effect to counter potential nausea from the use of an opioid. The
      use of supplemental nitrous oxide/oxygen (N2O/O2) in conjunction with a chosen sedation
      regimen has been shown to further potentiate sedation effects and improve sedation outcomes.

      Despite proving to be an effective behavior management technique, procedural sedation poses
      its own set of risks. Compared with intravenous or intranasal methods of drug delivery, oral
      delivery of sedation medications can be challenging due to longer and more variable onset to
      sedation, unpredictable hepatic first-pass absorption and bioavailability, and an inability
      to titrate the medications. Sedation effects may linger long after the procedure is completed
      and affect post-discharge outcomes. Additionally, the use of multiple medications has been
      shown to increase the risk of adverse outcomes compared with single or dual-combination drug
      regimens.

      The majority of adverse events during sedation can be avoided with careful case selection,
      medication dosing, and proper intra-operative monitoring. When adverse events do occur, they
      are typically due to respiratory depression, and can include laryngospasm, neurologic injury,
      and death. Thus, to avoid oversedation and subsequent adverse sequelae, multi-drug regimens
      (especially those that contain opioids like meperidine) must be used judiciously.

      The midazolam/meperidine/hydroxyzine regimen is a popular combination of medications for
      pediatric dental sedation. The increase in the use of meperidine has been associated with a
      movement away from utilization of chloral hydrate (another sedative with no reversal agent,
      previously frequently used in conjunction with a combination of the aforementioned drugs or
      other drugs). While there are studies comparing sedation regimens that include both chloral
      hydrate and meperidine used together, meperidine is an increasingly preferred option over
      chloral hydrate for procedural sedation, especially with the availability of a reversal agent
      for the opioid in the instance of oversedation, as well as a shorter half-life compared with
      chloral hydrate. While narcotic-containing regimens are popular, there are still inherent
      risks in utilization of an opioid in any sedation regimen. Several studies have been
      published comparing sedation regimens that include meperidine, but to date, there are no
      studies comparing the efficacy of midazolam and hydroxyzine with and without meperidine.
      Additionally, many studies compare side effects of different regimens (for example,
      post-operative drowsiness, nausea, time spent asleep, crying), but few utilize the Houpt
      Behavior Rating that we plan to use to categorize sedation outcomes.
    

Intervention name(s): Meperidine; Hydroxyzine; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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
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)
Primary purpose: Treatment