Clinical Trial

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

Recruiting Phase 4
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Summary
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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-12-24; most recent amendment 2026-03-30.
Status change: Not Yet Recruiting → Recruiting 2025-04-19
Trial Details
NCT Number NCT06757075
Lead Sponsor Boston University
Collaborators: Franciscan Hospital For Children, INC.
Conditions Pain, Postoperative
Enrollment 75 participants
Start Date 2025-04-16
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-12