About this trial
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
Qualifiers
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
Disqualifiers
ASA III or IV
Asthma diagnosis
Contraindication to acetaminophen or ibuprofen
Trial design
Treatments tested in this trial
- Ibuprofen
- Acetominophen
Treatment groups
Sponsors and collaborators
Boston University
Lead sponsor
Franciscan Hospital For Children, INC.
Collaborator