Pediatrics, McMaster University, Faculty of Health Sciences, Hamilton, Ontario, Canada
Department of Health Research Methods, Evidence & Impact, McMaster, Hamilton, Ontario, Canada.
BMJ Open. 2022 Apr 5;12(4):e056499. doi: 10.1136/bmjopen-2021-056499.
Despite a lack of evidence demonstrating superiority to non-steroidal anti-inflammatory drugs, like ketorolac, that are associated with lower risk of harms, opioids remain the most prescribed analgesic for acute abdominal pain. In this pilot trial, we will assess the feasibility of a definitive trial comparing ketorolac with morphine in children with suspected appendicitis. We hypothesise that our study will be feasible based on a 40% consent rate.
A single-centre, non-inferiority, blinded (participant, clinician, investigators and outcome assessors), double-dummy randomised controlled trial of children aged 6-17 years presenting to a paediatric emergency department with ≤5 days of moderate to severe abdominal pain (≥5 on a Verbal Numerical Rating Scale) and are investigated for appendicitis. We will use variable randomised blocks of 4-6 and allocate participants in 1:1 ratio to receive either intravenous (IV) ketorolac 0.5 mg/kg+IV morphine placebo or IV morphine 0.1 mg/kg+IV ketorolac placebo. Analgesic co-intervention will be limited to acetaminophen (commonly used as first-line therapy). Participants in both groups will be allowed rescue therapy (morphine 0.5 mg/kg) within 60 min of our intervention. Our primary feasibility outcome is the proportion of eligible patients approached who provide informed consent and are enrolled in our trial. Our threshold for feasibility will be to achieve a ≥40% consent rate, and we will enrol 100 participants into our pilot trial.
Our study has received full approval by the Hamilton integrated Research Ethics Board. We will disseminate our study findings at national and international paediatric research conferences to garner interest and engage sites for a future multicentre definitive trial.
NCT04528563, Pre-results.
尽管缺乏证据表明与副作用风险较低的非甾体抗炎药（如酮咯酸）相比具有优势，但阿片类药物仍然是治疗急性腹痛最常用的镇痛药物。在这项试点试验中，我们将评估比较酮咯酸和吗啡在疑似阑尾炎儿童中的疗效的确定性试验的可行性。我们假设根据 40%的同意率，我们的研究将是可行的。
一项单中心、非劣效性、双盲（参与者、临床医生、研究者和结果评估者）、双模拟随机对照试验，纳入年龄在 6-17 岁、就诊于儿科急诊、腹痛时间在 5 天内（数字评分法≥5 分）且疑似阑尾炎的儿童。我们将使用 4-6 个可变随机块，以 1:1 的比例将参与者随机分配至接受静脉（IV）酮咯酸 0.5mg/kg+IV 吗啡安慰剂或 IV 吗啡 0.1mg/kg+IV 酮咯酸安慰剂。镇痛辅助干预将仅限于对乙酰氨基酚（通常作为一线治疗药物）。两组参与者均允许在我们干预后 60 分钟内接受解救治疗（吗啡 0.5mg/kg）。我们的主要可行性结局是获得知情同意并入组我们试验的合格患者比例。我们的可行性标准是达到≥40%的同意率，我们将招募 100 名参与者参加我们的试点试验。
我们的研究已获得 Hamilton 综合研究伦理委员会的全面批准。我们将在全国和国际儿科研究会议上传播我们的研究结果，以引起兴趣并吸引更多的机构参与未来的多中心确定性试验。
NCT04528563，预注册。
