Pediatrics, University of Alberta, Edmonton, Alberta, Canada
Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.
BMJ Open. 2020 Jun 21;10(6):e035177. doi: 10.1136/bmjopen-2019-035177.
Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference.
Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019.
This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant.
NCT03767933, first registered on 07 December 2018.
肌肉骨骼（MSK）损伤是儿童急诊（ED）就诊的常见原因。MSK 损伤在大多数儿童中伴有中度至重度疼痛，但最近的研究证实，ED 中儿童疼痛的管理仍然不足。临床医生正在寻找更好的口服镇痛选择，用于 MSK 损伤疼痛，具有疗效和出色的安全性。本研究旨在确定口服对乙酰氨基酚或口服氢吗啡酮联合口服布洛芬治疗 MSK 损伤疼痛的疗效和安全性，并在家长/照顾者偏好的背景下解释这些信息。
使用一种新颖的偏好信息补充试验设计，正在进行两项同时进行的试验。急性肢体损伤就诊于 ED 的儿童的家长/照顾者将被接触，他们将决定他们希望参加哪个试验：包括阿片类药物的试验或不包括阿片类药物的试验。两项试验都将遵循随机、双盲、安慰剂对照、优效性试验方法，在加拿大六家儿科 ED 共招募至少 536 名儿童。如果儿童年龄在 6 至 17 岁之间，并且 ED 就诊时有急性肢体损伤和自我报告的口头数字评分量表疼痛评分≥5，他们将有资格参加。主要目的是确定口服布洛芬+口服氢吗啡酮与口服布洛芬+口服对乙酰氨基酚与口服布洛芬单独使用的有效性。招募于 2019 年 4 月开始。
该研究已获得阿尔伯塔大学健康研究伦理委员会和所有参与中心的适当伦理委员会的批准。将从所有参与者的父母/监护人那里获得知情同意，并获得参与者本人的同意。无论结果如何，研究数据都将提交发表。该研究得到了加拿大卫生研究院的资助。
NCT03767933，于 2018 年 12 月 7 日首次注册。
