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Dental Caries in ChildrenPhase 4NCT04068948

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

A Phase 4 study testing Meperidine, Hydroxyzine and Midazolam in people with Dental Caries in Children and Pediatric Dental Sedation, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 7 yearsHealthy volunteers can take part
What is being tested?
Meperidine, Hydroxyzine and Midazolam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
25 Jun 2019to 31 Jan 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 7 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington Center for Pediatric Dentistry

    Seattle, Washington, 98115

Other trials in United States

About this study

Official title: Comparing Pediatric Oral Sedation Outcomes Using Midazolam and Hydroxyzine With and Without Meperidine

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.

Read the 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.

Being tested
Meperidine, Hydroxyzine, Midazolam

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeperidineDrug

    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.

  • HydroxyzineDrug

    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.

  • MidazolamDrug

    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.

Study groups in NCT04068948
Study groupRoleWhat they receive
Midazolam, Hydroxyzine, MeperidineActive comparatorParticipants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.
Receives: Drug: Meperidine; Drug: Hydroxyzine; Drug: Midazolam
Midazolam, HydroxyzineExperimentalParticipants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.
Receives: Drug: Hydroxyzine; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Successful Sedation

    Children's behavior during sedation is rated on the Houpt Behavior Rating Scale. A successful sedation is rated as Excellent, Very Good, or Good. A failed sedation is rated as Fair, Poor, or Aborted.

    Measured: At completion of procedure

Secondary outcomes (1)
  1. Child Temperament According to CBQ-SF and Association With Sedation Outcomes

    Children's temperament will be assessed via parental completion of the Child Behavior Questionnaire Short Form (CBQ-SF) to assess which child temperaments may be more suitable candidates for dental oral sedation.

    The CBQ-SF is a set of 94 statements scoring a child's temperament on 15 domains: activity level, anger/frustration, approach/positive anticipation, attentional focusing, discomfort, falling reactivity/soothability, fear, high intensity pleasure, impulsivity, inhibitory control, low intensity pleasure, perceptual sensitivity, sadness, shyness, and smiling and laughter.

    There is no "better or worse outcome." The range is from 1 (minimum) to 7 (maximum) for all domains. A higher score indicates closer alignment with that temperament domain.

    Subscales of each primary domain (Effortful Control, Negative Affectivity, and Extraversion/Surgency) are combined and the sums averaged to create the total score for the 3 primary domains

    Measured: During procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start25 Jun 2019
  3. Primary completion31 Dec 2022
  4. Study completion31 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04068948
Sponsor's protocol ID
STUDY00006758
Status last verified
Dec 2023
First submitted
22 Aug 2019
Last updated
24 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ashley PF, Chaudhary M, Lourenco-Matharu L. Sedation of children undergoing dental treatment. Cochrane Database Syst Rev. 2018 Dec 17;12(12):CD003877. doi: 10.1002/14651858.CD003877.pub5.

    PubMed 30566228
  • Attri JP, Sharan R, Makkar V, Gupta KK, Khetarpal R, Kataria AP. Conscious Sedation: Emerging Trends in Pediatric Dentistry. Anesth Essays Res. 2017 Apr-Jun;11(2):277-281. doi: 10.4103/0259-1162.171458.

    PubMed 28663606
  • Chicka MC, Dembo JB, Mathu-Muju KR, Nash DA, Bush HM. Adverse events during pediatric dental anesthesia and sedation: a review of closed malpractice insurance claims. Pediatr Dent. 2012 May-Jun;34(3):231-8.

    PubMed 22795157
  • Chowdhury J, Vargas KG. Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients. Pediatr Dent. 2005 May-Jun;27(3):191-7.

    PubMed 16173222
  • Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.

    PubMed 10742324
  • Gentz R, Casamassimo P, Amini H, Claman D, Smiley M. Safety and Efficacy of 3 Pediatric Midazolam Moderate Sedation Regimens. Anesth Prog. 2017 Summer;64(2):66-72. doi: 10.2344/anpr-64-02-04.

    PubMed 28604093
  • Kain ZN, MacLaren J, McClain BC, Saadat H, Wang SM, Mayes LC, Anderson GM. Effects of age and emotionality on the effectiveness of midazolam administered preoperatively to children. Anesthesiology. 2007 Oct;107(4):545-52. doi: 10.1097/01.anes.0000281895.81168.c3.

    PubMed 17893449
  • Lane KJ, Nelson TM, Thikkurissy S, Scott JM. Assessing Temperament as a Predictor of Oral Sedation Success Using the Children's Behavior Questionnaire Short Form. Pediatr Dent. 2015 Sep-Oct;37(5):429-35.

    PubMed 26531085
  • McKee KC, Nazif MM, Jackson DL, Barnhart DC, Close J, Moore PA. Dose-responsive characteristics of meperidine sedation in preschool children. Pediatr Dent. 1990 Jul-Aug;12(4):222-7.

    PubMed 2077497
  • McCormack L, Chen JW, Trapp L, Job A. A comparison of sedation-related events for two multiagent oral sedation regimens in pediatric dental patients. Pediatr Dent. 2014 Jul-Aug;36(4):302-8.

    PubMed 25197995
  • Shapira J, Kupietzky A, Kadari A, Fuks AB, Holan G. Comparison of oral midazolam with and without hydroxyzine in the sedation of pediatric dental patients. Pediatr Dent. 2004 Nov-Dec;26(6):492-6.

    PubMed 15646910

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Meperidine, Hydroxyzine and Midazolam in people with Dental Caries in Children and Pediatric Dental Sedation, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Successful Sedation (time frame: At completion of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04068948, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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