跳至主要内容
临床试验/NCT00743730
NCT00743730已完成不适用

Outcomes And Parent Satisfaction Associated With Parent/Nurse Controlled Analgesia In Pediatric Patients With Developmental Delay

Medical College of Wisconsin2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2005年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
2
主要终点
Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale

研究概览

简要总结

The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.

详细描述

Children with developmental delay are at higher risk for inadequate pain assessment and management. Patient controlled analgesia (PCA) allows patients to administer opioids by pushing a PCA button when needed. This eliminates the delay of waiting for a nurse to obtain and administer pain medication. PCA has been shown to be safe, effective, and superior to intramuscular, intermittent opioid dosing for pain management in children. Often, children with developmental delays cannot operate a PCA independently, can not self report their pain and are often given pain medication "as needed" through an IV. Parent/Nurse Controlled Analgesia (PNCA) allows parents and nurses to push the PCA button for patients who are not able to do so themselves. This way of giving pain medicine has not been thoroughly studied. Some healthcare professionals use PNCA for these children, others do not. This study is being done to compare PNCA & intermittent opioid administration. Participants will be randomized into one of the three study groups:

  1. Parent/Nurse controlled Analgesia (PNCA) with a continuous intravenous (IV)infusion of pain medicine.
  2. PNCA without continuous IV infusion of pain medicine.
  3. Pain medicine given through IV administered on an "as needed" basis(PRN) by the nurse.

The Acute Pain Service will follow all three groups of patients throughout the study. This team specializes in the management of children's pain. Pain team is also available 24 hours a day, 7 days a week. The study will continue until child can tolerate pain medication in his/her stomach.

Data will be collected regarding safety, efficacy, parent & Nurse satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children with developmental delay between 4 and 18 years of age who are unable to operate PCA due to developmental delay.
  • Children scheduled for surgery anticipated to require >24hour stay with anticipation of IV narcotics will be required.
  • Children whose parents are able to verbalize an understanding of PNCA.
  • Parents with fluency in english(both speaking and writing).

排除标准

  • Patients who do not meet inclusion criteria
  • Patients whose parents do not give informed consent
  • patients allergic to both morphine and hydromorphone
  • patients with severe physiologically altering obstructive sleep apnea
  • Patients who are or are expected to remain on a ventilator
  • Patients receiving an epidural -

研究组 & 干预措施

I

Active Comparator

Parent and Nurse Controlled Analgesics with basal

干预措施: Pain and standard side effect management for PNCA with basal method. (Other)

II

Active Comparator

Parent and Nurse Controlled Analgesics without basal

干预措施: Pain and standard side effect management with PNCA without basal (Other)

III

Active Comparator

Intermittent opioid administered IV on an "as needed" basis

干预措施: Pain and standard side effect management with IV on an as needed basis method. (Other)

结局指标

主要结局

Median Pain Score During Shift 1, as Measured With the Face, Legs, Activity, Cry, Consolability Scale

时间窗: First 24 hours on study

Pain is measured with the Face, Legs, Activity, Cry, Consolability scale (FLACC) is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The median pain score over the first shift (24 hours) is reported.

次要结局

  • Number of Patients Requiring Naloxone for Respiratory Depression(Daily, for up to 3 days)
  • Parent Satisfaction With the Administration Technique(parents, once at the end of study)

研究者

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

Michelle Czarnecki

Advanced Practice Nurse

Medical College of Wisconsin

研究点 (2)

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