Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Recruiting now · Phase 4
Conditions studied: Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT06757075
- Run by
- Boston University
- People needed
- 75
- Starts
- 2025-04-16
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 4 and older, up to 6. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- ASA III or IV
- Asthma diagnosis
- Contraindication to acetaminophen or ibuprofen
Where it is running
- Franciscan Children's Hospital — Brighton, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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