Trial Outcomes & Findings for Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry (NCT NCT01971853)
NCT ID: NCT01971853
Last Updated: 2021-01-22
Results Overview
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
TERMINATED
NA
88 participants
60 minutes treatment started
2021-01-22
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 60 minutes treatment startedPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From state of treatment (time 0) 60 minutesPopulation: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of treatment (time 0) to 60 minutesPopulation: 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.
The differences in time and concentration of nitrous oxide used during treatment will be compared for each study arm.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 minutes after start of treatmentPopulation: 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.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 hours in clinicPopulation: 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.
The occurrence of Complications during treatment and recovery will be evaluated. Complications are defined as vomiting, excessive crying, need for supplemental oxygen, and disorientation.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours after patient is dischargedPopulation: 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.
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)
Outcome measures
Outcome data not reported
Adverse Events
Oral Placebo
Oral Analgesics
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Clinical Research Administration
University of Colorado Denver | Anschutz
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place