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Completed NCT06757075

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

Conditions: Pain, Postoperative

Sex: All
Ages: 4 Years – 6 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 28
Sponsor: Boston University

Location: Franciscan Children's Hospital Brighton Massachusetts

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 Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06757075). StuddyBuddy aggregates publicly available trial information.