Clinical trial NCT05126459: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety, Dental
Dental Decay
Keywords: Pediatric
Dental
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Inclusion criteria included patients of record who were scheduled to undergo oral sedation at Loma Linda University Pediatric Dentistry clinic for dental treatment. Children ages ranged from 3 to 6 years old with no medical issues, ASA-1. The reason for oral sedation was situational anxiety in the dental operatory. Exclusion criteria included children who presented with a history of: (1) acute illness; (2) upper respiratory tract infection within two weeks of treatment; (3) taking any medication within the two weeks prior to scheduled dental treatment; and (4) a body mass index (BMI) greater than the 95th percentile for their age and gender. A total sample of 60 healthy pediatric patients were included in this study with were no gender, race, or ethnic significant difference.

The included patients were randomly allocated into one of three sedation groups by drawing a concealed folded paper from an opaque randomization bag after obtaining parent consent. All papers that were used in the randomization had the same size and texture. The pediatric dental resident and attending faculty were informed with medication combination once randomized allocation had been made.

The study groups were as follows: Group 1 received Midazolam (0.5- 0.75 mg/kg), Meperidine (1.5-2.0 mg/kg), and Hydroxyzine (1.5- 2.0 mg/kg), Group 2 received Meperidine (1.5-2 mg/kg) and Hydroxyzine (1.5- 2.0 mg/kg). Group 3 received Midazolam (0.5- 0.75 mg/kg) and Hydroxyzine (1.5- 2mg/kg).

Clinical Procedure Calculations based on the child's weight of maximum local anesthetic delivery, oral sedation medication dosages, and reversal agents were completed prior to delivery of medication. The reversal agent used for benzodiazepines was Flumazenil, 0.01mg/Kg with a maximum of 0.2 mg/dose. While the reversal agent for Meperidine was Naloxone, calculated as 0.1 mg/Kg up to 2 mg.

After obtaining proper consents, all patients were placed in passive protective stabilization (Joey Board®, Joey Board, Queen Creek, AZ) in the event the child was to become uncooperative and to maintain patient stability during treatment, as coordination could be impaired. Nitrous oxide/Oxygen (N2O/O2) was used in all sedations and administered at a flow rate of four to six L/minute (30-50% N2O/ 10-50% O2) with 100% O2 given for five minutes pre- and postoperatively. All operating dentists followed standard sedation protocol at standard sedation protocol in Loma Linda University Pediatric Dentistry Clinic adapted from the American Academy of Pediatric Dentistry (AAPD) guidelines.8 Routine dental care was provided with local anesthesia with rubber dam or isolite® isolation. Xylocaine (2% lidocaine with 1:100,000 epinephrine) was used for local anesthesia in all cases and did not exceed 4 mg/kg lidocaine. Once AAPD discharge criteria8 were met, the patient was released to the parent. At that time, postoperative care instructions, including emergency contact numbers and recommendation for over-the-counter pain medications, if needed, were provided both verbally and in written form.

The dentist performing each sedation was asked to complete a detailed questionnaire that provided details about the patient's behavior from the time of drug administration to the time of discharge (Survey 1). In addition, parents received two telephone interviews regarding events that occurred after the sedation session. An investigator conducted all phone interviews. These phone interviews took place at eight hours (Survey 2) and 24 hours (Survey 3) after discharge.

For all three of the surveys, questions were designed to elucidate patient physical signs and/or behaviors that fell into the following categories: (1) sleep disturbances; (2) gastrointestinal side effects; (3) non-aggressive behavior changes; (4) residual central nervous system alterations; (5) respiratory depression; (6) musculoskeletal effects; (7) physical reactions; (8) existence of a paradoxical reaction; and (9) amnesic effects. Information on the pre-sedation cooperation level and overall effectiveness of the sedation (rated as ineffective, effective, very effective, or overly sedated) were obtained from the procedural sedation record (adopted from AAPD) corresponding to each case.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Adverse Sedation-Related Events in Musculoskeletal System During Sedation
timeFrame: during sedation
measure: Incidence of Adverse Sedation-Related Events in Musculoskeletal in 8 Hours
timeFrame: Change 8 (eight) hours post oral sedation medication administration
measure: Incidence of Adverse Sedation-Related Events in Musculoskeletal at 24 Hours After Sedation
timeFrame: Change between 24 (twenty-four) hours post oral sedation
measure: Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction During Sedation
timeFrame: During sedation
measure: Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 8 Hours After Sedation
timeFrame: 8 hours after sedation
measure: Compare Incidence of Adverse Effect Related to Gastrointestinal Reaction 24 Hours After Sedation
timeFrame: 24 hours after sedation
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Jung-Wei Chen, DDS,MS,PhD
role: PRINCIPAL_INVESTIGATOR
References: