Pain, Postoperative
Conditions
Keywords
Dental rehabilitation under general anesthesia (DRGA), Dental surgery patients 4-6 years, Acetominophen, Ibuprofen, Pacing analgesics
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.
Interventions
DRUGIbuprofen
10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
DRUGAcetominophen
15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Sponsors
Boston University
Franciscan Hospital For Children, INC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental discomfort assessed by the abbreviated DDQ-8 | day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery | The Dental Discomfort Questionnaire (DDQ-8)-Abbreviated is an 8 item questionnaire completed by the caregiver. Responses to each question are Yes=2 and No=0 creating a possible range of total scores of 0-16 with higher scores correlated with more dental discomfort. |
| Pain assessment based on the FLACC | day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery | The Face, Legs, Activity, Cry, and Consolability (FLACC) scale assesses pain by the caregiver on 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; (C) consolability. Each behavior is rated 0 to 2 resulting in a range of scores from 0 to 10 with higher scores correlated with more pain. |
Countries
United States
Contacts
CONTACTKeri Discepolo, DDS MPH
PRINCIPAL_INVESTIGATORKeri Discepolo, DDS MPH
BU Goldman School of Dental Medicine, Pediatrics
Outcome results
None listed