RecruitingPhase 4NCT06757075

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

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


Sponsor

Boston University

Enrollment

75 participants

Start Date

Apr 16, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 6 Years

Inclusion Criteria4

  • 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 Criteria3

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

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Interventions

DRUGIbuprofen

10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery

DRUGAcetominophen

15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery


Locations(1)

Franciscan Children's Hospital

Brighton, Massachusetts, United States

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NCT06757075


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