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临床试验/NCT06402019
NCT06402019已完成不适用

Repeated Dexmedetomidine Infusion is a Two-shot Weapon for Pain and Pain-induced Mood Disorders in Chronic Pain Patients

Benha University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月1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
100
试验地点
1
主要终点
The extent of reduction of consumed analgesics

研究概览

简要总结

Chronic pain (CP) was defined as pain experienced daily or on most days and induced restriction of at least one activity. CP is one of the commonest complaints confronted in outpatient clinics and constitutes a challenge for all medical provisions. CP is a multifaceted condition; postoperative CP is frequently encountered in clinical practice and may be of debilitating severity leading to worse quality of life (QOL) especially CP with a neuropathic component as post-mastectomy pain syndrome and post-amputation pain and chronic post-sternotomy pain that seriously impacts patients' QOL and affects patient recovery till 12 months after cardiac surgery. Chronic musculoskeletal pain as defined by the International Pain Association is the persistent or recurrent pain involving spine, bones, joints, and/or musculo-soft tissue.

Chronic pain was considered as a long-lasting stressor that might induce disordered mood varying between depression and anxiety with consequent challenge of this combination on treatment outcomes and consumption of health resources. This necessitated psychological screening of CP patient to identify and manage patients with disordered mood to improve CP treatment outcomes.

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
Single (Participant)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with multiple-level spinal canal stenosis who refused surgical management.

排除标准

  • Patients with other causes for CP;
  • maintained on opioid analgesia;
  • had cardiac lesions;
  • maintained on antihypertensive therapy;
  • hepatic impairment;
  • Patients can't attend the clinic to complete the course of Dexmedetomidine infusion sessions.

研究组 & 干预措施

Intervention Group

Active Comparator

干预措施: Dexmedetomidine in 0.9 % NaCl 20 Mcg/5 mL (4 Mcg/mL) INTRAVEN SYRINGE (ML) (Drug)

Control Group

Placebo Comparator

干预措施: normal saline (Drug)

结局指标

主要结局

The extent of reduction of consumed analgesics

时间窗: 6 months

Necessity of Dexmedetomidine infusion as management procedure to the chronic pain patients

次要结局

未报告次要终点

研究者

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

Salsabil Sayed Abdelkader

Clinical lecturer at Department of Anesthesia, Pain & ICU, Faculty of Medicine

Benha University

研究点 (1)

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