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RECRUITING
NCT06757075
PHASE4

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

Sponsor: Boston University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

4 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2025-04-16

Completion Date

2027-03

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

Ibuprofen

10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery

DRUG

Acetominophen

15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery

Locations (1)

Franciscan Children's Hospital

Brighton, Massachusetts, United States