跳至主要内容
临床试验/NCT00580151
NCT00580151终止不适用

The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2004年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
1
主要终点
Pain Reduction

研究概览

简要总结

Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.

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
Double (Participant, Investigator)

入排标准

年龄范围
4 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pain not controled by morphine
  • Anxiety not controled by lorazepam
  • Burn injuries of 20% or greater
  • Burn type: scald or flame

排除标准

  • Small burn injury
  • Electrical burns

研究组 & 干预措施

1

Experimental

干预措施: clonidine (Drug)

2

Placebo Comparator

干预措施: placebo (Drug)

结局指标

主要结局

Pain Reduction

时间窗: Average of the 10 days

The scale name is "FACES" (Faces Pain Rating Scale). Subjects were asked "rate your WORST PAIN today" (0 = no pain at all, 1-4 = mild pain, 5-6 = moderate pain, 7-9 = severe pain, 10 = excruciating pain). The Faces Pain Rating Scale should be collected every day and then averaged.

次要结局

  • Anxiety Reduction(Average of the 10 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验