Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry (Analgesia)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
|Official Title:||Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?|
- Improved sedation effectiveness based on numerical value for effectiveness as noted in description [ Time Frame: 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
- Difference in heart rate as measured by numerical delta value [ Time Frame: 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.
- Time of administration of nitrous oxide and oxygen as measured by minutes and percent of nitrous oxide administered [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)
|Study Start Date:||October 2013|
|Study Completion Date:||December 31, 2016|
|Primary Completion Date:||December 31, 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: oral placebo
an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen
Drug: oral placebo
Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen
Other Name: Flavored liquid
Active Comparator: Oral Analgesics
5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen
Drug: Oral Analgesics
Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971853
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Study Director:||Jeffrey O Young, DDS||University of Colorado, Denver|