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.
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
ASA III or IV
Asthma diagnosis
Contraindication to acetaminophen or ibuprofen
Parallel
Ibuprofen
Drug10 mg/kg/dose of ibuprofen will be given every 6 hours for 24 hours post surgery
Acetominophen
Drug15 mg/kg/dose of acetominophen will be given every 6 hours for 24 hours post surgery
Dental discomfort assessed by the abbreviated DDQ-8
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
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.
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Boston University
Lead sponsor
Franciscan Hospital For Children, INC.
Collaborator
