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

Anxiety, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126459
• Other study ID #: 5190213
• Status: Completed
• Phase: Phase 3
• Start date: February 14, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: November 2023
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 12, 2023
• Est. primary completion date: April 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety, Dental
• Dental Caries
• Dental Decay

Intervention

Combination Product:
• Regimen 1
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 #2
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 #3
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.

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.
Primary	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.	Change between 8 (eight) hours post oral sedation medication administration and discharge and 24 (twenty-four) hours post oral sedation medication administration and discharge.
Primary	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.	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	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	24 (twenty-four) hours post oral sedation medication administration (composite measurement)