Phase 3
N=60
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Anxiety, Dental · Dental Decay
Bottom Line
View on ClinicalTrials.gov: NCT05126459 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation — 2.8; 3; 2.5500 score on a scale — p=0.016
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Regimen 1 (Combination_product); Regimen #2 (Combination_product); Regimen #3 (Combination_product)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Loma Linda University
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation |
2.8; 3; 2.5500 | 0.016 sig |
| PRIMARY Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours |
0.5; 0.2; 0.2 | 0.211 |
| PRIMARY Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation |
0.05; 0; 0 | 0.374 |
| PRIMARY Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation |
0.1; 0.05; 0 | 0.55 |
| PRIMARY Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation |
0.25; 0; 0.05 | 0.16 |
| PRIMARY Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation |
0.2; 0; 0 | 0.012 sig |
Summary
This study will compare the post sedation events from three different multi-drug oral sedation regimens in order to help pediatric dentists determine the best course of action for their patients and prepare parents appropriately and caution them about the expected effects. Patients will be evaluated for adverse effects within two time periods at 8 and 24 hours post oral sedation procedure using surveys.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.
- Age 3-7 years old, Healthy ( ASA-1 )
- No gender, race or ethnic restrictions.
- Reason for conscious oral sedation is situational anxiety in the dental operatory
Exclusion Criteria
- Children with a history of acute illness
- History upper respiratory tract infection within two weeks of treatment
- Children taking any medication within the two weeks prior to scheduled dental treatment
- Sedation within the last six months
- Body mass index (BMI) greater than the 95th percentile for their age and sex
- Failing to drink the entire amount of sedation medications dispensed
Data sourced from ClinicalTrials.gov (NCT05126459). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.