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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age4-6
SponsorBoston University

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

75 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Boston University

Lead sponsor

Franciscan Hospital For Children, INC.

Collaborator