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

Part of paid clinical trials in Brighton, Massachusetts.

Sponsor
Boston University
Study ID
NCT06757075
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
4 Years - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Ibuprofen — DRUG
    10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
  • Acetominophen — DRUG
    15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Franciscan Children's HospitalBrightonMassachusetts02135
Keri Discepolo, DDS MPH
[email protected]
617-358-3446

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By research site
Franciscan Children's Hospital· Brighton, MA

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