Back to resultsA Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Primary Purpose
Anxiety, Dental, Dental Decay
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Regimen 1
Regimen #2
Regimen #3
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety, Dental focused on measuring Pediatric, Dental
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.
- Age 3-6 years, 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
Sites / Locations
- Loma Linda UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Regimen 1
Regimen 2
Regimen 3
Arm Description
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)
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) -
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)
Outcomes
Primary Outcome Measures
Incidence of Adverse Sedation-Related Events in Regimen #1
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.
Incidence of Adverse Sedation-Related Events in Regimen #2
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.
Incidence of Adverse Sedation-Related Events in Regimen #3
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.
Secondary Outcome Measures
Compare incidence of adverse effect related to the use of three medications versus two medications
Compare the number and type of adverse effect related (Amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) to the use of three medications versus two medications.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05126459
Brief Title
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Official Title
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Dental, Dental Decay
Keywords
Pediatric, Dental
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Regimen 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Regimen 2
Arm Type
Experimental
Arm Description
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) -
Arm Title
Regimen 3
Arm Type
Experimental
Arm Description
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)
Intervention Type
Combination Product
Intervention Name(s)
Regimen 1
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Regimen #2
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Regimen #3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Adverse Sedation-Related Events in Regimen #1
Description
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.
Time Frame
Change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.
Title
Incidence of Adverse Sedation-Related Events in Regimen #2
Description
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.
Time Frame
Change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.
Title
Incidence of Adverse Sedation-Related Events in Regimen #3
Description
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.
Time Frame
Change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.
Secondary Outcome Measure Information:
Title
Compare incidence of adverse effect related to the use of three medications versus two medications
Description
Compare the number and type of adverse effect related (Amount and frequency of sleeping, level of activity, gastrointestinal discomfort, central nervous system, respiratory depression, paradoxical reactions) to the use of three medications versus two medications.
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
Time Frame
24 (twenty-four) hours post oral sedation medication administration (composite measurement)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to undergo oral sedation appointments in Loma Linda University Pediatric dental clinic for operative procedures.
Age 3-6 years, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Wei Chen, DDS,MS,PhD
Phone
(909) 558-4690
Email
jwchen@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam Alkheder, DDS
Phone
(909) 558-4690
Email
Malkheder@students.llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Wei Chen, DDS,MS,PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Alkheder, DDS
Email
malkheder@students.llu.edu
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Oral Sedation-related Events of Three Multiagent Oral Sedation Regimens in Pediatric Dental Patients
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