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

NCT01971853 | Terminated Results

• 1 other identifier: 13-1753
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in Heart Rate as Measured by Numerical Delta Value

  From state of treatment (time 0) 60 minutes

Other Outcomes (4)

• Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered

  From start of treatment (time 0) to 60 minutes

• Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description

  60 minutes after start of treatment

• Complications During Treatment and Recovery

  2 hours in clinic

Study Arms (2)

oral placebo

PLACEBO COMPARATOR

an Ibuprofen and Acetaminophen Placebo will be added to a Demerol-Vistaril regimen

Drug: oral placebo

Oral Analgesics

ACTIVE COMPARATOR

5 mg/kg ibuprofen + 15 mg/kg acetaminophen will be added to a Demerol-Vistaril regimen

Drug: Oral Analgesics

Interventions

oral placebo DRUG

Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen

Also known as: Flavored liquid

oral placebo

Oral Analgesics DRUG

Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen

Oral Analgesics

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Limitations and Caveats

The study was terminated early due to recruitment issues. The PI has left the institution. Significant efforts were made to obtain the data by contacting the PI and the study team members, but those efforts were unsuccessful and we could obtain no results data. No study data are available.

Results Point of Contact

• Title: Director, Clinical Research Administration
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

Study Officials

• Jeffrey O Young, DDS

  University of Colorado, Denver

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2020-12

Locations

US (1)