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

NCT04068948 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: STUDY00006758
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Dental Caries in Children; Pediatric Dental Sedation; Meperidine; Hydroxyzine; Midazolam

Outcome Measures

Primary Outcomes (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.

  At completion of procedure

Secondary Outcomes (1)

• Child Temperament According to CBQ-SF and Association With Sedation Outcomes

  During procedure

Study Arms (2)

Midazolam, Hydroxyzine, Meperidine

ACTIVE COMPARATOR

Participants 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.

Drug: Meperidine; Drug: Hydroxyzine; Drug: Midazolam

Midazolam, Hydroxyzine

EXPERIMENTAL

Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.

Drug: Hydroxyzine; Drug: Midazolam

Interventions

Meperidine DRUG

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.

Midazolam, Hydroxyzine, Meperidine

Hydroxyzine DRUG

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.

Midazolam, Hydroxyzine; Midazolam, Hydroxyzine, Meperidine

Midazolam DRUG

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.

Midazolam, Hydroxyzine; Midazolam, Hydroxyzine, Meperidine

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Center for Pediatric Dentistry

Seattle, Washington, 98115, United States

Location

Related Publications (11)

• 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.

  PMID: 30566228 BACKGROUND

• 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.

  PMID: 28663606 BACKGROUND

• 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.

  PMID: 22795157 BACKGROUND

• 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.

  PMID: 16173222 BACKGROUND

• 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.

  PMID: 10742324 BACKGROUND

• 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.

  PMID: 28604093 BACKGROUND

• 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.

  PMID: 17893449 BACKGROUND

• 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.

  PMID: 26531085 BACKGROUND

• 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.

  PMID: 2077497 BACKGROUND

• 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.

  PMID: 25197995 BACKGROUND

• 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.

  PMID: 15646910 BACKGROUND

MeSH Terms

Interventions

Meperidine; Hydroxyzine; Midazolam

Intervention Hierarchy (Ancestors)

Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Piperazines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Travis Nelson
• Organization: University of Washington

tmnelson@uw.edu

206-543-0980

Study Officials

• Travis M Nelson, DDS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant is unaware of the regimen given. The care provider and investigator(s) are aware of the regimen given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, School of Dentistry

Model Details: This is a randomized clinical trial where participants are assigned randomly to receive a sedation regimen of either midazolam+hydroxyzine+meperidine or midazolam+hydroxyzine.

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: June 25, 2019
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: January 24, 2024
• Results First Posted: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)