Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?

Conditions
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Pain

Intervention / Treatment
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* Drug: oral placebo
* Drug: Oral Analgesics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study. Exclusion Criteria: Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: oral placebo<br>an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen | Drug: oral placebo<br>* Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen<br>* Other names: Flavored liquid;|
| Active Comparator: Oral Analgesics<br>5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen | Drug: Oral Analgesics<br>* Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia