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NCT06757075PHASE4Recruiting

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

Boston University

Start Date

4/16/2025

Completion Date

3/1/2027

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

Age Range: 4 years to 6 years

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

Interventions

DRUG

Ibuprofen

DRUG

Acetominophen

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Conditions

Pain, Postoperative

Locations

Franciscan Children's Hospital

Brighton, Massachusetts 02135

United States