Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.

Conditions
-----------------
Earache

Intervention / Treatment
-----------------
* Drug: Pregabalin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: referred otalgia ENT cancer ASA score 1,2 or 3 understanding protocol information and free and informed consent Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pregabalin group<br> | Drug: Pregabalin<br>* 150mg daily in three doses during three weeks<br>|
| Placebo Comparator: Placebo group<br> | Drug: Placebo<br>* Three doses daily with lactose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decreased intensity of pain in referred otalgia | diminution of the pain intensity numerical rating scale (NRS) | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuropathic pain | diminution of the Neuropathic Pain Scale Inventory (NPSI) | Three weeks | 
| Numeric rating Scale | referred otalgia after surgery: intensity | one, three and six months | 
| Neuropathic Pain Symptom Inventory | referred otalgia after surgery: presence | one, three and six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic pain, ent cancer, pregabalin