Pain
Conditions
Keywords
Analgesia
Brief summary
All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.
Detailed description
To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.
Interventions
DRUGoral placebo
Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen
DRUGOral Analgesics
Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.
Exclusion criteria
* Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description | 60 minutes treatment started | A Sedation effectiveness evaluation criteria chart will be utilized to determine a numerical value for the effectiveness as follows: 1 = Effective/Excellent; 2 = Partially effective/good; 3 = Ineffective/fair; 4 = Aborted/Poor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Heart Rate as Measured by Numerical Delta Value | From state of treatment (time 0) 60 minutes | A baseline heart rate will be determined at the beginning of the appointment, and a maximum heart rate will be determined during the appointment. The differences between baseline and maximum heart rates for each study arm will be compared. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered | From start of treatment (time 0) to 60 minutes | The differences in time and concentration of nitrous oxide used during treatment will be compared for each study arm. |
| Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description | 60 minutes after start of treatment | A table will be used to determine the complexity of procedures performed by assigning a numerical value to each procedure and determining a total procedure complexity score. |
| Complications During Treatment and Recovery | 2 hours in clinic | The occurrence of Complications during treatment and recovery will be evaluated. Complications are defined as vomiting, excessive crying, need for supplemental oxygen, and disorientation. |
| Post Operative Problems | 4 hours after patient is discharged | Presence of Post op problems including time and whether problem is constant or intermittent will be as follows: Discomfort when eating/drinking (D), Resumption of normal activity (NA), and Need for additional pain meds (PM) |
Countries
United States
Participant flow
Pre-assignment details
The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Participants by arm
| Arm | Count |
|---|---|
| Oral Placebo an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen
oral placebo: Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen | 0 |
| Oral Analgesics 5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen
Oral Analgesics: Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description
A Sedation effectiveness evaluation criteria chart will be utilized to determine a numerical value for the effectiveness as follows: 1 = Effective/Excellent; 2 = Partially effective/good; 3 = Ineffective/fair; 4 = Aborted/Poor
Time frame: 60 minutes treatment started
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Secondary
Difference in Heart Rate as Measured by Numerical Delta Value
A baseline heart rate will be determined at the beginning of the appointment, and a maximum heart rate will be determined during the appointment. The differences between baseline and maximum heart rates for each study arm will be compared.
Time frame: From state of treatment (time 0) 60 minutes
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Other Pre-specified
Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description
A table will be used to determine the complexity of procedures performed by assigning a numerical value to each procedure and determining a total procedure complexity score.
Time frame: 60 minutes after start of treatment
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Other Pre-specified
Complications During Treatment and Recovery
The occurrence of Complications during treatment and recovery will be evaluated. Complications are defined as vomiting, excessive crying, need for supplemental oxygen, and disorientation.
Time frame: 2 hours in clinic
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Other Pre-specified
Post Operative Problems
Presence of Post op problems including time and whether problem is constant or intermittent will be as follows: Discomfort when eating/drinking (D), Resumption of normal activity (NA), and Need for additional pain meds (PM)
Time frame: 4 hours after patient is discharged
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.
Other Pre-specified
Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered
The differences in time and concentration of nitrous oxide used during treatment will be compared for each study arm.
Time frame: From start of treatment (time 0) to 60 minutes
Population: The study was terminated and the PI has left the institution. Significant efforts were made to obtain the data by contacting the PI/study team members, but those efforts were unsuccessful. No study data are available.