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

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 Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: oral placebo; Drug: Oral Analgesics

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered	The differences in time and concentration of nitrous oxide used during treatment will be compared for each study arm.	From start of treatment (time 0) to 60 minutes
Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description	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.	60 minutes after start of treatment
Complications During Treatment and Recovery	The occurrence of Complications during treatment and recovery will be evaluated. Complications are defined as vomiting, excessive crying, need for supplemental oxygen, and disorientation.	2 hours in clinic
Post Operative Problems	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)	4 hours after patient is discharged

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Study Director: Jeffrey O Young, DDS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): December 31, 2016
• Study Completion (ACTUAL): December 31, 2016

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (ESTIMATE): October 29, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: 13-1753