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

NCT06757075 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Franciscan Hospital For Children, INC.

    collaborator OTHER

  • Boston University

    lead OTHER

Principal Investigators

  • Keri Discepolo, DDS MPH · BU Goldman School of Dental Medicine, Pediatrics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06757075 on ClinicalTrials.gov