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

NCT05126459 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 5190213
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety, Dental; Dental Decay

Keywords

Pediatric; Dental

Outcome Measures

Primary Outcomes (6)

• Incidence of Adverse Sedation-Related Events in Musculoskeletal System 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.

  during sedation

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

  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.

  Change 8 (eight) hours post oral sedation medication administration

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

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

• Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 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

  During sedation

• Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 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.

  8 hours after sedation

• Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 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

  24 hours after sedation

Study Arms (3)

Regimen 1

ACTIVE COMPARATOR

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Meperidine (1.5 -2 mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)

Combination Product: Regimen 1

Regimen 2

EXPERIMENTAL

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration- Meperidine (1.5 -2 mg/kg) Inhalation - Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) -

Combination Product: Regimen #2

Regimen 3

EXPERIMENTAL

Oral administration - Hydroxyzine (1.5 - 2mg/kg) Oral administration - Midazolam (0.5- 0.75 mg/kg) Inhalation- Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2)

Combination Product: Regimen #3

Interventions

Regimen 1 COMBINATION_PRODUCT

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5- 2mg/kg) + Meperidine (1.5 -2 mg/kg) + Midazolam (0.5- 0.75 mg/kg) In combination with oral drugs stated above, administeration via inhalation of Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.

Regimen 1

Regimen #2 COMBINATION_PRODUCT

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Meperidine (1.5 -2 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.

Regimen 2

Regimen #3 COMBINATION_PRODUCT

Administer orally after informed consent obtained prior to any dental procedure. Hydroxyzine (1.5 - 2mg/kg) + Midazolam (0.5- 0.75 mg/kg). Administer Nitrous oxide/oxygen (30-50% N2O/ 70-50% O2) via inhalation.

Regimen 3

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Dental Caries

Interventions

ICE protocol 3

Condition Hierarchy (Ancestors)

Mental Disorders; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

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.

Results Point of Contact

• Title: Dr. Jung-Wei Chen
• Organization: Loma Linda University Health

JWChen@llu.edu

909 558 1000

Study Officials

• Jung-Wei Chen, DDS,MS,PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, Pediatric Dentistry

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: November 19, 2021
• Study Start: February 14, 2022
• Primary Completion: April 11, 2023
• Study Completion: April 12, 2023
• Last Updated: October 2, 2024
• Results First Posted: October 2, 2024

Record last verified: 2024-09

Locations

US (1)