Actively Recruiting
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Led by Boston University · Updated on 2026-04-02
75
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
Sponsors
B
Boston University
Lead Sponsor
F
Franciscan Hospital For Children, INC.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children classified as American Society of Anesthesiologists (ASA) physical status I or II
- Require oral rehabilitation under general anesthesia
- Have a legal guardian proficient in English
- No history of allergic or adverse reactions to NSAIDs or acetaminophen
You will not qualify if you...
- Children classified as ASA physical status III or IV
- Diagnosis of asthma
- Contraindications to acetaminophen or ibuprofen
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Franciscan Children's Hospital
Brighton, Massachusetts, United States, 02135
Actively Recruiting
Research Team
K
Keri Discepolo, DDS MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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