Actively Recruiting

Phase 4
Age: 4Years - 6Years
All Genders
NCT06757075

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

Led by Boston University · Updated on 2026-04-02

75

Participants Needed

1

Research Sites

97 weeks

Total Duration

On this page

Sponsors

B

Boston University

Lead Sponsor

F

Franciscan Hospital For Children, INC.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 6Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children classified as American Society of Anesthesiologists (ASA) physical status I or II
  • Require oral rehabilitation under general anesthesia
  • Have a legal guardian proficient in English
  • No history of allergic or adverse reactions to NSAIDs or acetaminophen
Not Eligible

You will not qualify if you...

  • Children classified as ASA physical status III or IV
  • Diagnosis of asthma
  • Contraindications to acetaminophen or ibuprofen

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Franciscan Children's Hospital

Brighton, Massachusetts, United States, 02135

Actively Recruiting

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Research Team

K

Keri Discepolo, DDS MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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