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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Dental discomfort assessed by the abbreviated DDQ-8
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •ASA III or IV
- •Asthma diagnosis
- •Contraindication to acetaminophen or ibuprofen
研究组 & 干预措施
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.
干预措施: Acetominophen (Drug)
Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
干预措施: Ibuprofen (Drug)
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.
干预措施: Ibuprofen (Drug)
Simultaneous post-operative analgesics
Participants randomized into this arm will be given simultaneous Ibuprofen and Acetaminophen every 6 hours for 24 hours.
干预措施: Acetominophen (Drug)
Control Standard of Care
Participants randomized into this arm will be given Ibuprofen every 6 hours for 24 hours.
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Dental discomfort assessed by the abbreviated DDQ-8
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点