Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ibuprofen, Acetominophen.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: 4 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparison of Standard Dose of Ibuprofen Alone, Alternating, or Combined With Acetaminophen for the Management of Postoperative Discomfort in Young Children Following Dental Rehabilitation Under General Anesthesia
Overview
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.
Interventions
- Drug Ibuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery - Drug Acetominophen
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Franciscan Children's Hospital — Brighton
Identifiers
NCT: NCT06757075 · H-001FC