Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01971853
|Contact: Jeffrey O Young, DDSfirstname.lastname@example.org|
|Contact: Ulrich Klein, DDSemail@example.com|
|United States, Colorado|
|Children's Hospital Colorado||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Jeffrey O Young, DDS 720-777-8895 firstname.lastname@example.org|
|Principal Investigator: Jeffrey O Young, DDS|
|Study Director:||Jeffrey O Young, DDS||University of Colorado, Denver|