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

March 30, 2026 updated by: Boston University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Keri Discepolo, DDS MPH
  • Phone Number: 617-358-3446
  • Email: kdiscep@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Recruiting
        • Franciscan Children's Hospital
        • Contact:
          • Keri Discepolo, DDS MPH
          • Phone Number: 617-358-3446
          • Email: kdiscep@bu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • ASA III or IV
  • Asthma diagnosis
  • Contraindication to acetaminophen or ibuprofen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Other Names:
  • Motrin
Drug: Acetominophen
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Other Names:
  • Tylenol
Experimental: Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
Drug: Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Other Names:
  • Motrin
Drug: Acetominophen
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Other Names:
  • Tylenol
Active Comparator: Control Standard of Care
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
Drug: Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Other Names:
  • Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental discomfort assessed by the abbreviated DDQ-8
Time Frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
The Dental Discomfort Questionnaire (DDQ-8)-Abbreviated is an 8 item questionnaire completed by the caregiver. Responses to each question are Yes=2 and No=0 creating a possible range of total scores of 0-16 with higher scores correlated with more dental discomfort.
day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
Pain assessment based on the FLACC
Time Frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale assesses pain by the caregiver on 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; (C) consolability. Each behavior is rated 0 to 2 resulting in a range of scores from 0 to 10 with higher scores correlated with more pain.
day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

Franciscan Hospital For Children, INC.

Investigators

  • Principal Investigator: Keri Discepolo, DDS MPH, BU Goldman School of Dental Medicine, Pediatrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-001FC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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