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

Not Applicable

Terminated

• Conditions: Pain
• Interventions: Drug: oral placebo; Drug: Oral Analgesics

• Registration Number: NCT01971853
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-29
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2020-12
• Results First Submitted: 2020-12-28
• Results First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Results First Posted: 2021-01-22
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 88

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.

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Exclusion Criteria

• Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral placebo	oral placebo	an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen
Oral Analgesics	Oral Analgesics	5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen

Primary Outcome Measures

Name	Time	Method
Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description	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

Secondary Outcome Measures

Name	Time	Method
Difference in Heart Rate as Measured by Numerical Delta Value	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States