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 range3 Years – 7 Years

SexALL

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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

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