Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry (Analgesia)
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|ClinicalTrials.gov Identifier: NCT01971853|
Recruitment Status : Terminated (Insufficient number of participants recruited)
First Posted : October 29, 2013
Last Update Posted : March 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: oral placebo Drug: Oral Analgesics||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
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
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971853
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Study Director:||Jeffrey O Young, DDS||University of Colorado, Denver|