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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Primary and study completion dates: Mar 2026 to Mar 2027v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2025 to Apr 16, 2025
    • Site details revised
    v5
  4. Start date: Mar 2025 to Jun 2025v4
  5. Start date: Feb 2025 to Mar 2025v3
  6. Start date: Jan 2025 to Feb 2025v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06757075
Lead Sponsor Boston University
Collaborators: Franciscan Hospital For Children, INC.
Conditions
(from sponsor)		 Pain, Postoperative
Related terms Postoperative Pain
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov