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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 6
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Franciscan Children's Hospital
RECRUITING
Brighton
Contact Information
Primary
Keri Discepolo, DDS MPH
kdiscep@bu.edu
617-358-3446
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2026-03
Participants
Target number of participants: 75
Treatments
Experimental: Alternating analgesics
Participants randomized into this arm will be given alternating Ibuprofen and Acetaminophen every 6 hours, alternating the two medications every 3 hours: first dose ibuprofen, three hours later acetaminophen for 24 hours.
Experimental: Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Active_comparator: Control Standard of Care
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
Related Therapeutic Areas
Sponsors
Collaborators: Franciscan Hospital For Children, INC.
Leads: Boston University

This content was sourced from clinicaltrials.gov

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