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

This study has been terminated.
(Insufficient number of participants recruited)
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01971853
First received: October 18, 2013
Last updated: March 23, 2017
Last verified: March 2017
  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: Triple (Participant, Care Provider, 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 ]

    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 ]
    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 ]
    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)


Enrollment: 35
Study Start Date: October 2013
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (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   (Child)
Sexes Eligible for Study:   All
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

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Director: Jeffrey O Young, DDS University of Colorado, Denver
  More Information

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: March 23, 2017

Keywords provided by University of Colorado, Denver:
Analgesia

Additional relevant MeSH terms:
Acetaminophen
Ibuprofen
Analgesics
Meperidine
Hydroxyzine
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Adjuvants, Anesthesia
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 18, 2017