NCT06757075

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Boston University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-16
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-01-03
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study