Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06757075

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Franciscan Children's Hospital

Brighton, Massachusetts, 02135, United States

Location status: Recruiting

Location contact

Keri Discepolo, DDS MPH

CONTACT

[email protected]

617-358-3446

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen

Drug

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

Other names: Motrin

Acetominophen

Drug

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

Other names: Tylenol

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keri Discepolo, DDS MPH

CONTACT

[email protected]

617-358-3446

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Franciscan Hospital For Children, INC.

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 3, 2025
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.