Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada.
Division of Neonatology, Department of Pediatrics, McMaster University, Hamilton, ON, Canada.
PLoS One. 2023 Nov 20;18(11):e0294519. doi: 10.1371/journal.pone.0294519. eCollection 2023.
In neonates, uncontrolled pain and opioid exposure are both correlated with short- and long-term adverse events. Therefore, managing pain using opioid-sparing approaches is critical in neonatal populations. Multimodal pain control offers the opportunity to manage pain while reducing short- and long-term opioid-related adverse events. Intravenous (IV) acetaminophen may represent an appropriate adjunct to opioid-based postoperative pain control regimes. However, no trials assess this drug in patients less than 36 weeks post-conceptual age or weighing less than 1500 g.
The proposed study aims to determine the feasibility of conducting a randomized control trial to compare IV acetaminophen and fentanyl to a saline placebo and fentanyl for patients admitted to the neonatal intensive care unit (NICU) undergoing major abdominal or thoracic surgery.
This protocol is for a single-centre, external pilot randomized controlled trial (RCT). Infants in the NICU who have undergone major thoracic or abdominal surgery will be enrolled. Sixty participants will undergo 1:1 randomization to receive intravenous acetaminophen and fentanyl or saline placebo and fentanyl. After surgery, IV acetaminophen or placebo will be given routinely for eight days (192 hours). Appropriate dosing will be determined based on the participant's gestational age. Patients will be followed for eight days after surgery and will undergo a chart review at 90 days. Primarily feasibility outcomes include recruitment rate, follow-up rate, compliance, and blinding index. Secondary clinical outcomes will be collected as well.
This external pilot RCT will assess the feasibility of performing a multicenter RCT comparing IV acetaminophen and fentanyl to a saline placebo and fentanyl in NICU patients following major abdominal and thoracic surgery. The results will inform the design of a multicenter RCT, which will have the appropriate power to determine the efficacy of this treatment.
ClinicalTrials.gov NCT05678244, Registered December 6, 2022.
在新生儿中，无法控制的疼痛和阿片类药物暴露都与短期和长期不良事件相关。因此，在新生儿人群中，采用阿片类药物节约方法来管理疼痛至关重要。多模式疼痛控制提供了在减轻短期和长期阿片类药物相关不良事件的同时管理疼痛的机会。静脉内（IV）对乙酰氨基酚可能是阿片类药物为基础的术后疼痛控制方案的一种合适的辅助手段。然而，没有试验评估这种药物在出生后不到 36 周或体重不足 1500 克的患者中的情况。
本研究旨在确定开展一项随机对照试验（RCT）来比较静脉内对乙酰氨基酚和芬太尼与生理盐水安慰剂和芬太尼用于接受主要腹部或胸部手术的新生儿重症监护病房（NICU）患者的可行性。
这是一项单中心、外部先导性 RCT 方案。在接受了重大胸部或腹部手术后的 NICU 中，将纳入 60 名参与者进行 1:1 随机分组，接受静脉内对乙酰氨基酚和芬太尼或生理盐水安慰剂和芬太尼。手术后，将常规给予 IV 对乙酰氨基酚或安慰剂 8 天（192 小时）。适当的剂量将根据参与者的胎龄确定。患者将在手术后 8 天内进行随访，并在 90 天时进行图表审查。主要可行性结果包括招募率、随访率、依从性和盲法指数。还将收集次要临床结果。
这项外部先导性 RCT 将评估在接受重大腹部和胸部手术后的 NICU 患者中开展一项比较 IV 对乙酰氨基酚和芬太尼与生理盐水安慰剂和芬太尼的多中心 RCT 的可行性。结果将为多中心 RCT 的设计提供信息，该 RCT 将具有适当的能力来确定这种治疗方法的疗效。
ClinicalTrials.gov NCT05678244，注册于 2022 年 12 月 6 日。
