Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- decreased intensity of pain in referred otalgia
研究概览
简要总结
Referred otalgia is one of the symptoms of oropharynx and hypopharynx cancer. It can be primary (otodynia) or secondary (referred otalgia and projected pain). The mechanism of referred otalgia involves several non adjacent nerve territories as those of head, neck or ear. Referred otalgia is a projected pain due to injury (most of the time cancer) localized far from the ear but sharing the same innervation. In this contest, the otoscopy is normal.
Four cranial nerves participate in the sensory innervation of the external ear: the trigeminal nerve (V) via the auriculo temporal nerve (V3), the facial nerve (VII) for the Ramsay-Hunt's zone with the conch, tragus, antitragus, a part of the anthelix, of the external auditory meatus and of the eardrum, the glossopharyngeal nerve (IX) via the Jacobson's nerve for the external ear canal and the C2 and C3 cervical plexus. However, there are important interindividual anatomical variations.
The relationship between referred otalgia and probable nerve damage has been described. In he oropharynx and hypopharynx, the proximity of the sensory innervation of the ear can then explain the otalgia during the cancer progression. Then referred otalgia has a neuropathic component.
In the literature, the curative treatment of referred otalgia is the cancer treatment. However, the high intensity of referred otalgia leads the patients to a large consumption of analgesics in particular of opioids. These latter are particularly adapted for pain resulting from excess of nociceptive stimulation. Pregabalin (Lyrica®) is an analogue of gamma aminobutyric acid. This molecule binds to alpha subunit 2 delta 1 calcium dependent voltage channels in the central nervous system. its effectiveness has been demonstrated for the treatment of neuropathic pain on diabetic neuropathy, post herpetic neuralgia, lesions in the bone marrow but also the postoperative pain when the molecule is administered after the surgery. The anti hyperalgesic activity of pregabalin is at a dosage of 150mg/day in two or three daily doses.
The purpose of this study was to evaluate the activity of pregabalin administered orally for three weeks after the anesthesia consultation on the intensity of the pain of referred otalgia and on its neuropathic component.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •referred otalgia
- •ENT cancer
- •ASA score 1,2 or 3
- •understanding protocol
- •information and free and informed consent
排除标准
- •ASA score 4 et 5
- •allergy or intolerance of pregabalin
- •creatinin clearance inferior of 50ml/min (Cockcroft formula)
- •liver failure
- •cardiac failure
- •history epilepsy
- •ant hyperalgesic treatment
- •minor or disabled adult
- •intellectual disabilities that prevent the understanding of the protocol
- •uncooperative patient
- •pregnant women
- •patient participating in another research protocol
- •lactose intolerant patient
研究组 & 干预措施
pregabalin group
干预措施: Pregabalin (Drug)
Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
decreased intensity of pain in referred otalgia
时间窗: three weeks
diminution of the pain intensity numerical rating scale (NRS)
次要结局
- neuropathic pain(Three weeks)
- Numeric rating Scale(one, three and six months)
- Neuropathic Pain Symptom Inventory(one, three and six months)