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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 4 Years and 6 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Boston University

Study Contact

Keri Discepolo, DDS MPH
617-358-3446
kdiscep@bu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.