Trial · NCT04068948
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
NCT04068948, Phase 4, Completed, University of Washington; results first posted 2023-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years. Trials, record NCT04068948. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04068948
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years
- NCT number
- NCT04068948
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 37 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Dental Caries in Children, Pediatric Dental Sedation, Meperidine, Hydroxyzine, Midazolam
- Interventions
- Meperidine, Hydroxyzine, Midazolam
- First posted
- 2019-08-28
- Last updated
- 2024-01-24
- Results first posted
- 2023-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Successful Sedation | 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. |
| Secondary | Child Temperament According to CBQ-SF and Association With Sedation Outcomes | 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 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Successful Sedation | At completion of procedure | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Child Temperament According to CBQ-SF and Association With Sedation Outcomes | During procedure | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Successful Sedation | Midazolam, Hydroxyzine, Meperidine | 11 | Participants | ||
| Number of Participants With Successful Sedation | Midazolam, Hydroxyzine | 9 | Participants | ||
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine, Meperidine | Effortful Control | 5.38 | Standard Deviation 0.47 | score on a scale |
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine | Effortful Control | 5.84 | Standard Deviation 0.81 | score on a scale |
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine, Meperidine | Negative Affectivity | 4.44 | Standard Deviation 0.75 | score on a scale |
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine | Negative Affectivity | 4.12 | Standard Deviation 0.43 | score on a scale |
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine, Meperidine | Extraversion/Surgency | 4.30 | Standard Deviation 0.46 | score on a scale |
| Child Temperament According to CBQ-SF and Association With Sedation Outcomes | Midazolam, Hydroxyzine | Extraversion/Surgency | 4.21 | Standard Deviation 0.50 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Midazolam, Hydroxyzine, Meperidine | 20 | |
| Overall Study | STARTED | Midazolam, Hydroxyzine | 17 | |
| Overall Study | COMPLETED | Midazolam, Hydroxyzine, Meperidine | 20 | |
| Overall Study | COMPLETED | Midazolam, Hydroxyzine | 17 | |
| Overall Study | NOT COMPLETED | Midazolam, Hydroxyzine, Meperidine | 0 | |
| Overall Study | NOT COMPLETED | Midazolam, Hydroxyzine | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Midazolam, Hydroxyzine, Meperidine | 0 | 20 |
| Total, all-cause mortality | Midazolam, Hydroxyzine | 0 | 17 |
| Total, other adverse events | Midazolam, Hydroxyzine, Meperidine | 0 | 20 |
| Total, other adverse events | Midazolam, Hydroxyzine | 0 | 17 |
| Total, serious adverse events | Midazolam, Hydroxyzine, Meperidine | 0 | 20 |
| Total, serious adverse events | Midazolam, Hydroxyzine | 0 | 17 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Midazolam, Hydroxyzine, Meperidine vs Midazolam, Hydroxyzine: Number of Participants With Successful Sedation | Trial comparisons |
| Midazolam, Hydroxyzine, Meperidine vs Midazolam, Hydroxyzine: deaths from any cause | Trial comparisons |
| Midazolam, Hydroxyzine, Meperidine vs Midazolam, Hydroxyzine: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04068948
GET https://conductscience.org/api/trials/v1/NCT04068948/registered