CompletedPhase 3

A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients

United States60 participantsStarted 2022-02-14

Plain-language 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.

Who can participate

Age range

3 Years – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation

Timeframe: during sedation

Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours

Timeframe: Change 8 (eight) hours post oral sedation medication administration

Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation

Timeframe: Change between 24 (twenty-four) hours post oral sedation

Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation

Timeframe: During sedation

Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation

Timeframe: 8 hours after sedation

Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation

Timeframe: 24 hours after sedation

Trial details

NCT IDNCT05126459

SponsorLoma Linda University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

Results submitted2024-01-18

View on ClinicalTrials.gov More Anxiety, Dental trials