Trial · NCT05126459
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
NCT05126459, Phase 3, Completed, Loma Linda University; results first posted 2024-10-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients. Trials, record NCT05126459. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05126459
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
- NCT number
- NCT05126459
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Loma Linda University
- Conditions
- Anxiety, Dental, Dental Decay
- Interventions
- Regimen 1, Regimen #2, Regimen #3
- First posted
- 2021-11-19
- Last updated
- 2024-10-02
- Results first posted
- 2024-10-02
- Limitations and caveats
The dentists providing sedation were trained to evaluate behavior parameters, but there may have been difficulty in quantifying parameters due to experience and assessment subjectivity.~All dental treatment was performed with physical stabilization devices, which may have potentially altered the ability to evaluate some of the patients' responses. The postoperative phone calls proved challenging due to difficulty reaching the guardians within the 24 hour phone call window period.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation | during sedation | Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge Musculoskeletal system reaction during sedation scale: This is the result for Musculoskeletal related questions, it is a sum of 3 yes or no questions. (minimum=0, maximum=3) The higher the worse. |
| Primary | Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours | Change 8 (eight) hours post oral sedation medication administration | Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. Musculoskeletal system reaction at 8 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse. |
| Primary | Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation | Change between 24 (twenty-four) hours post oral sedation | Compare the incidence of adverse sedation related events (categories: amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) between three different multi-agent oral sedation regimens in LLUSD pediatric dental patients who were scheduled for oral sedation. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. Musculoskeletal system reaction at 24 hours scale: This is the result for Musculoskeletal related questions, it is a sum of 2 yes or no questions. (minimum=0, maximum=2) The higher the worse. |
| Primary | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation | During sedation | Compare the number and type of adverse effect related gastrointestinal reactions. Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty-four) hours (Survey 3) after discharge. GI effect for during sedation score; This is a summary of 3 yes/no questions, Minimum = 0 Maximum =3, the higher means more GI reactions, the worse outcome |
| Primary | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation | 8 hours after sedation | Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge. GI effect 8 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome. |
| Primary | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation | 24 hours after sedation | Compare the number and type of adverse effect related gastrointestinal reactions Data will be collected in the form of 3 survey sets: the surveys is survey set 1 are written surveys to be completed by the dentist (Survey 1), and survey sets 2\&3 are phone surveys to be conducted by the researcher with the parents 8 (eight) hours (Survey 2) and 24 (twenty four) hours (Survey 3) after discharge. Long term effect for 24 hours after sedation score; This is a summary of 5 yes/no questions, Minimum = 0 Maximum =5, the higher means more GI reactions, the worse outcome |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation | during sedation | score on a scale | MEAN | |
| PRIMARY | Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours | Change 8 (eight) hours post oral sedation medication administration | score on a scale | MEAN | |
| PRIMARY | Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation | Change between 24 (twenty-four) hours post oral sedation | score on a scale | MEAN | |
| PRIMARY | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation | During sedation | score on a scale | MEAN | |
| PRIMARY | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation | 8 hours after sedation | score on a scale | MEAN | |
| PRIMARY | Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation | 24 hours after sedation | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation | Regimen 1 | 2.8 | 95% Confidence Interval 2.67 to 3 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation | Regimen 2 | 3 | 95% Confidence Interval 3 to 3 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation | Regimen 3 | 2.5500 | 95% Confidence Interval 2.2 to 2.9 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours | Regimen 1 | 0.5 | 95% Confidence Interval 0.11 to 0.88 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours | Regimen 2 | 0.2 | 95% Confidence Interval 0.007 to 0.39 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours | Regimen 3 | 0.2 | 95% Confidence Interval 0.044 to 0.44 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation | Regimen 1 | 0.05 | 95% Confidence Interval 0.005 to 0.15 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation | Regimen 2 | 0 | 95% Confidence Interval 0 to 0 | score on a scale | |
| Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation | Regimen 3 | 0 | 95% Confidence Interval 0 to 0 | score on a scale | |
| Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation | Regimen 1 | 0.1 | 95% Confidence Interval 0.10 to 0.30 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Regimen 1 | 20 | |
| Overall Study | STARTED | Regimen 2 | 20 | |
| Overall Study | STARTED | Regimen 3 | 20 | |
| Overall Study | COMPLETED | Regimen 1 | 20 | |
| Overall Study | COMPLETED | Regimen 2 | 20 | |
| Overall Study | COMPLETED | Regimen 3 | 20 | |
| Overall Study | NOT COMPLETED | Regimen 1 | 0 | |
| Overall Study | NOT COMPLETED | Regimen 2 | 0 | |
| Overall Study | NOT COMPLETED | Regimen 3 | 0 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sleep Disturbance | Nervous system disorders | Regimen 1 | 1 | 20 | |
| other | Sleep Disturbance | Nervous system disorders | Regimen 2 | 0 | 20 | |
| other | Sleep Disturbance | Nervous system disorders | Regimen 3 | 0 | 20 | |
| other | Non-Aggressive Behavioral Changes | Nervous system disorders | Regimen 1 | 1 | 20 | |
| other | Non-Aggressive Behavioral Changes | Nervous system disorders | Regimen 2 | 0 | 20 | |
| other | Non-Aggressive Behavioral Changes | Nervous system disorders | Regimen 3 | 1 | 20 | |
| other | Gastrointestinal Upset | Gastrointestinal disorders | Regimen 1 | 1 | 20 | |
| other | Gastrointestinal Upset | Gastrointestinal disorders | Regimen 2 | 0 | 20 | |
| other | Gastrointestinal Upset | Gastrointestinal disorders | Regimen 3 | 0 | 20 | |
| other | Respiratory Effects | Respiratory, thoracic and mediastinal disorders | Regimen 1 | 2 | 20 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Regimen 1 | 0 | 20 |
| Total, all-cause mortality | Regimen 2 | 0 | 20 |
| Total, all-cause mortality | Regimen 3 | 0 | 20 |
| Total, other adverse events | Regimen 1 | 7 | 20 |
| Total, other adverse events | Regimen 2 | 1 | 20 |
| Total, other adverse events | Regimen 3 | 1 | 20 |
| Total, serious adverse events | Regimen 1 | 0 | 20 |
| Total, serious adverse events | Regimen 2 | 0 | 20 |
| Total, serious adverse events | Regimen 3 | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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