RECRUITING

Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to investigate the effectiveness of various oral analgesic regimens in minimizing post-operative pain and discomfort in young children following dental rehabilitation under general anesthesia (DRGA). In this randomized controlled trial, three analgesic regimens following DRGA in Franciscan Children's Hospital will be compared using both self-report and behavioral measures. The analgesic therapies to be investigated are ibuprofen monotherapy, alternating ibuprofen and acetaminophen dual-therapy, and combined ibuprofen and acetaminophen dual-therapy. For the purposes of this study, combined therapy is defined as the simultaneous administration of acetaminophen and ibuprofen at regular intervals, whereas alternating therapy is defined as one analgesic (acetaminophen or ibuprofen) administered within a 3 hour interval of the other.

Official Title

A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia

Quick Facts

Study Start:2025-04-16
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06757075

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * American Society of Anesthesiologists (ASA) I-II
  2. * Requiring Oral Rehabilitation under General Anesthesia
  3. * Possess legal guardians proficient in English
  4. * Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen
  1. * ASA III or IV
  2. * Asthma diagnosis
  3. * Contraindication to acetaminophen or ibuprofen

Contacts and Locations

Study Contact

Keri Discepolo, DDS MPH
CONTACT
617-358-3446
kdiscep@bu.edu

Principal Investigator

Keri Discepolo, DDS MPH
PRINCIPAL_INVESTIGATOR
BU Goldman School of Dental Medicine, Pediatrics

Study Locations (Sites)

Franciscan Children's Hospital
Brighton, Massachusetts, 02135
United States

Collaborators and Investigators

Sponsor: Boston University

  • Keri Discepolo, DDS MPH, PRINCIPAL_INVESTIGATOR, BU Goldman School of Dental Medicine, Pediatrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • Dental rehabilitation under general anesthesia (DRGA)
  • Dental surgery patients 4-6 years
  • Acetominophen
  • Ibuprofen
  • Pacing analgesics

Additional Relevant MeSH Terms

  • Pain, Postoperative