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临床试验/NCT05853263
NCT05853263已完成不适用

Pediatric Analgesia After Cardiac Surgery; Morphine IV Versus Paracetamol IV After Cardiac Surgery in Neonates and Infants.

Erasmus Medical Center0 个研究点目标入组 208 人开始时间: 2016年3月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
208
主要终点
The primary outcome measure is weight-adjusted cumulative morphine dose in the first 48 hours post-operatively.

研究概览

简要总结

The goal of this clinical trial is to compare pain management in neonates and infants under 3 years of age undergoing cardiac surgery with use of cardiopulmonary bypass. Patients will be randomized to either continuous morphine IV (standard) of intermittent paracetamol IV (intervention).

The investigators' hypothesis is that intermittent IV paracetamol is effective as the primary analgesic drug in post-cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements.

详细描述

Congenital heart disease accounts for almost one third of all congenital anomalies. Surgical intervention is necessary in 55% within the first year of life and in 67% during the first three years of life.

Morphine is the drug of first choice worldwide for pain relief after major surgery in neonates and children. However, morphine can cause unwanted hemodynamic and respiratory reactions and therefore patients could potentially benefit from a non-opioid analgesic.

In a recent randomized controlled trial, intravenous (IV) paracetamol was compared with morphine as a primary analgesic drug in non-cardiac post-operative children up to 1 year. IV paracetamol was equally effective in pain relief, and no difference in rescue analgesics was shown between groups. The IV paracetamol group had a lower cumulative morphine dose the first 48 h after surgery and less adverse drug reactions.

Whether these results also apply to neonates and children after cardiac surgery is unclear. Pharmacokinetic (PK) parameters are assumed to be different in patients during and after cardiac surgery compared with non-cardiac surgery due to use of the cardiopulmonary bypass (CPB).

Hypothesis The investigators' hypothesis is that intermittent IV paracetamol is effective as the primary analgesic drug in post-cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

double blind, randomized

入排标准

年龄范围
1 Day 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Informed consent
  • Neonates/infants who are 0-36 months old
  • Cardiac surgery with the use of CPB.

排除标准

  • No informed consent
  • Known allergy to or intolerance of paracetamol or morphine
  • Administration of opioids in the 24 h prior to surgery
  • Hepatic dysfunction defined as three times the reference value of alanine aminotransferase/aspartate aminotransferase (ALAT/ASAT)
  • Renal insufficiency at least RIFLE category Risk prior to surgery.

研究组 & 干预措施

morphine

Other

Standard care, continuous morphine IV.

干预措施: Morphine (Drug)

paracetamol

Active Comparator

intervention group, intermittent paracetamol IV

干预措施: paracetamol (Drug)

结局指标

主要结局

The primary outcome measure is weight-adjusted cumulative morphine dose in the first 48 hours post-operatively.

时间窗: 48 hours

dose in micrograms per kilogram

次要结局

  • The length of PICU stay(immediately after surgery)
  • Role of alarmins in the systemic inflammatory response (only at Wilhelmina Children's hospital)(48 hours)
  • Analysis of plasma morphine and paracetamo levels in relation to dose after cardia surgery using NONMEM (non-lineair mixed effects modelling).(48 hours)
  • Incidence of adverse drug reactions(96 hours)
  • Non-inferiority analysis of comparing the proportion of patients with one or more Numaric Rating Scale (NRS) scores of at least 4 between groups(48 hours)
  • The role of genetic polymorphisms in morphine metabolism(directly before surgery)
  • Concomitant use of sedatives(48 hours)
  • mechanical ventilation duration in hours(immediately after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerdien (G.A.) Zeilmaker-Roest

clinical investigator

Erasmus Medical Center

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