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

NCT06757075 | Recruiting Phase 4 FDA Drug

• 1 other identifier: H-001FC
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental rehabilitation under general anesthesia (DRGA); Dental surgery patients 4-6 years; Acetominophen; Ibuprofen; Pacing analgesics

Outcome Measures

Primary Outcomes (2)

• Dental discomfort assessed by the abbreviated DDQ-8

  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

  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

Study Arms (3)

Alternating analgesics

EXPERIMENTAL

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; Drug: Acetominophen

Simultaneous post-operative analgesics

EXPERIMENTAL

Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.

Drug: Ibuprofen; Drug: Acetominophen

Control Standard of Care

ACTIVE COMPARATOR

Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

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

Also known as: Motrin

Alternating analgesics; Control Standard of Care; Simultaneous post-operative analgesics

Acetominophen DRUG

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

Also known as: Tylenol

Alternating analgesics; Simultaneous post-operative analgesics

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Boston University: lead
• Franciscan Hospital For Children, INC.: collaborator

Study Sites (1)

Franciscan Children's Hospital

Brighton, Massachusetts, 02135, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Keri Discepolo, DDS MPH

  BU Goldman School of Dental Medicine, Pediatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keri Discepolo, DDS MPH

CONTACT

617-358-3446; kdiscep@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: April 16, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)