Oral Versus Intravenous Acetaminophen for the Treatment of Pain Secondary to Long Bone Fracture Requiring Surgery in Children
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in pain scores
研究概览
简要总结
Intravenous (IV) acetaminophen entered the Canadian market recently and children with acute pain following a trauma are ideal candidates for the IV formulation as it may improve analgesia and consequently decrease the amount of opioids needed to achieve pain control. Due to the limited data on bioavailability, adverse effect profile and efficacy of IV versus oral acetaminophen, it is of paramount importance to generate evidence-based data to guide clinicians with a rational choice of route of administration of acetaminophen.
Therefore, we propose a pilot study to inform a future large randomized controlled trial (RCT) to compare pharmacokinetics, feasibility, preliminary effects and side effects profile of oral versus IV acetaminophen in children admitted for surgical fixation of a long-bone fracture.
详细描述
Patients admitted for a long-bone fracture needing surgical fixation are generally initially treated with intranasal and/or IV opioids in association to oral acetaminophen and ibuprofen. Following surgery they are treated with a combination of morphine and acetaminophen. To address the issue of opioid epidemics, the Pediatric Orthopaedic Society of North America recommends reduction of their prescription as much as possible by promoting, among others, use of multimodal analgesia after surgery. The current proposal aims to improve post-operative pain control in children following a surgical fixation of a long-bone fracture and decrease the use of opioids through better co-analgesia. As such, this study aims to assess the pharmacokinetics (PK) and the efficacy of oral versus IV formulations of acetaminophen after surgery for long bone fractures in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Likely to undergo surgery for a long-bone fracture
- •Aged between 2-18 years (IV acetaminophen is approved for children ≥2 years)
- •IV line per standard of care
排除标准
- •Contraindication to oral drug administration
- •Patients unable to take oral solution
- •Known hypersensitivity or allergy to acetaminophen or any of the excipients in the IV or oral formulation
- •Use of any medication known to interact with acetaminophen including, but not restricted to phenytoin and carbamazepine (1)
- •Pregnancy
- •Known Hepatic insufficiency or hepatic disease
- •Known or diagnosed severe renal failure
- •Multiple trauma (more than two long bone fractures)
- •Hemodynamic or respiratory compromise
- •Altered level of consciousness (Glasgow coma scale <15)
研究组 & 干预措施
Oral acetaminophen arm
they will receive oral acetaminophen, placebo (saline) IV
干预措施: Acetaminophen (Drug)
IV acetaminophen arm
they will receive IV acetaminophen, placebo oral
干预措施: Acetaminophen IV (Drug)
结局指标
主要结局
Change in pain scores
时间窗: During 24h (starting with the first dose of study drug)
Pain scores within the first 24 hours following initiation of study drug, using the scales Face, Legs, Activity, Cry, Consolability (FLACC, 0-2 per item for a total of 10, 10 being the worst pain) and verbal numerical rating (VNR, 0-10, 10 being the worst pain).
Difference in quantity of rescue opioids
时间窗: During 24h (starting with the first dose of study drug)
Quantity of rescue opioids (morphine equivalent in mg/kg) within the first 24 hours following initiation of study drug
次要结局
- Adverse events(During 24h (starting with the first dose of study drug))
- Determination of oral bioavailability(During 24 hours after the first dose of study drug)
研究者
Dr. Niina Kleiber
Paediatrician and Clinical Pharmacologist
St. Justine's Hospital