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

Phase 4RecruitingNCT06757075

Boston University75 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain, Postoperative

Interventions

Eligibility

Sex: ALLMin age: 4 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: day of surgery, one pay post surgery, 2 days post surgery, 15 days post surgery

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.