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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01971853
First received: October 18, 2013
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Pain
Drug: oral placebo
Drug: Oral Analgesics

Study Type: Interventional
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?

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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



Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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)


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971853

Contacts
Contact: Jeffrey O Young, DDS 720-777-8895 jeffrey.young@childrenscolorado.org
Contact: Ulrich Klein, DDS 720-777-2791 ulrich.klein@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeffrey O Young, DDS    720-777-8895    jeffrey.young@childrenscolorado.org   
Principal Investigator: Jeffrey O Young, DDS         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Director: Jeffrey O Young, DDS University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01971853     History of Changes
Other Study ID Numbers: 13-1753
Study First Received: October 18, 2013
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Analgesia

Additional relevant MeSH terms:
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Acetaminophen
Meperidine
Hydroxyzine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014