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

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

Recruiting
4-6 years
All
Phase 4

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Overview

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.

Eligibility

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) I-II
  • Requiring Oral Rehabilitation under General Anesthesia
  • Possess legal guardians proficient in English
  • Not have a history of any adverse/allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs) or Acetaminophen

Exclusion Criteria:

  • ASA III or IV
  • Asthma diagnosis
  • Contraindication to acetaminophen or ibuprofen

Study details
    Pain
    Postoperative

NCT06757075

Boston University

29 April 2025

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