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Insufficient number of participants recruited
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral placebo | Placebo Comparator | an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen |
|
| Oral Analgesics | Active Comparator | 5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral placebo | Drug | Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 60 minutes treatment started |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From state of treatment (time 0) 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of treatment (time 0) to 60 minutes |
| Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey O Young, DDS | University of Colorado, Denver | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Oral Analgesics |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | 60 minutes treatment started |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The study was terminated early due to recruitment issues. The PI has left the institution. Significant efforts were made to obtain the data by contacting the PI and the study team members, but those efforts were unsuccessful and we could obtain no results data. No study data are available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research Administration | University of Colorado Denver | Anschutz | clinicalresearchsupportcenter@ucdenver.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| Oral Analgesics | Drug | Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen |
|
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. |
| 60 minutes after start of treatment |
| 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. | 2 hours in clinic |
| 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) | 4 hours after patient is discharged |
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
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| 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 |
|
| 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. | 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. | Posted | From state of treatment (time 0) 60 minutes |
|
|
| 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. | 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. | Posted | From start of treatment (time 0) to 60 minutes |
|
|
| 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. | 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. | Posted | 60 minutes after start of treatment |
|
|
| 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. | 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. | Posted | 2 hours in clinic |
|
|
| 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) | 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. | Posted | 4 hours after patient is discharged |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |