Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
NCT ID: NCT06757075
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
75 participants
INTERVENTIONAL
2025-04-16
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
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
Control Standard of Care
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Asthma diagnosis
* Contraindication to acetaminophen or ibuprofen
4 Years
6 Years
ALL
No
Sponsors
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Franciscan Hospital For Children, INC.
OTHER
Boston University
OTHER
Responsible Party
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Principal Investigators
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Keri Discepolo, DDS MPH
Role: PRINCIPAL_INVESTIGATOR
BU Goldman School of Dental Medicine, Pediatrics
Locations
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Franciscan Children's Hospital
Brighton, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-001FC
Identifier Type: -
Identifier Source: org_study_id
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