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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
Who can join
Ages 4 to 6 · All sexes
Full 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
About the study
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.
What is being tested
- Ibuprofen (drug)
- Acetominophen (drug)
Sponsor: Boston University · Participants: 75 · Started: Apr 16, 2025
Contact the study team
- Rua Milaeh, DDS MPH · Phone: 617-358-3446
Official record on ClinicalTrials.gov — NCT06757075
Locations in the U.S.
| Massachusetts | Franciscan Children's Hospital, Brighton |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.