Trial Outcomes & Findings for Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years (NCT NCT04068948)

Last Updated: 2024-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

At completion of procedure

Results posted on

2024-01-24

Participant Flow

Children scheduled for dental treatment with oral moderate sedation at the University of Washington Center for Pediatric Dentistry were recruited for the study from 2019-2022

Participant milestones

Participant milestones
Measure	Midazolam, Hydroxyzine, Meperidine Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.	Midazolam, Hydroxyzine Participants assigned to this group will receive a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.
Overall Study STARTED	20	17
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Midazolam, Hydroxyzine, Meperidine n=20 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.	Midazolam, Hydroxyzine n=17 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.	Total n=37 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	69.15 months n=5 Participants	69.23 months n=7 Participants	69.19 months n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	17 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: At completion of procedure

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.

Outcome measures

Outcome measures
Measure	Midazolam, Hydroxyzine, Meperidine n=20 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.	Midazolam, Hydroxyzine n=17 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.
Number of Participants With Successful Sedation	11 Participants	9 Participants

SECONDARY outcome

Timeframe: During procedure

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

Outcome measures

Outcome measures
Measure	Midazolam, Hydroxyzine, Meperidine n=19 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, Hydroxyzine 1.0mg/kg, and Meperidine 1.5mg/kg prior to their dental procedure.	Midazolam, Hydroxyzine n=17 Participants Participants assigned to this group received a regimen of Midazolam 0.5mg/kg, and Hydroxyzine 1.0mg/kg prior to their dental procedure.
Child Temperament According to CBQ-SF and Association With Sedation Outcomes Effortful Control	5.38 score on a scale Standard Deviation 0.47	5.84 score on a scale Standard Deviation 0.81
Child Temperament According to CBQ-SF and Association With Sedation Outcomes Negative Affectivity	4.44 score on a scale Standard Deviation 0.75	4.12 score on a scale Standard Deviation 0.43
Child Temperament According to CBQ-SF and Association With Sedation Outcomes Extraversion/Surgency	4.30 score on a scale Standard Deviation 0.46	4.21 score on a scale Standard Deviation 0.50

Adverse Events

Midazolam, Hydroxyzine, Meperidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Midazolam, Hydroxyzine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Travis Nelson

University of Washington

Phone: 206-543-0980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place