Recruiting

Postoperative Discomfort

Sponsor:

Boston University

Code:

NCT06757075

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Not accepted

Interventions

Ibuprofen

Acetominophen

Study Details

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

Study ID

NCT06757075

Start date

Apr 16, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 6

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

experimental: Simultaneous post-operative analgesics

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

active comparator: Control Standard of Care

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

Interventions

Ibuprofen

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

Acetominophen

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

Primary outcome measure

  • 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 ]
  • Pain assessment based on the FLACC [ Time Frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery ]

Central Contacts and Locations

Central contacts

Rua Milaeh, DDS MPH

617-358-3446milaeh@bu.edu

Locations

Franciscan Children's Hospital

Recruiting

Brighton, Massachusetts, United States, 02135

Contacts

Keri Discepolo, DDS MPH

617-358-3446kdiscep@bu.edu

More Information

Sponsor

Boston University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston University on 2026-08-12.