Earache Clinical Trial
— LYRORLOfficial title:
Interest of Pregabalin (Lyrica) on the Treatment of Reflex Earache in Head and Neck Cancer.
| Verified date | November 2017 |
| Source | University Hospital, Lille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 42 |
| Est. completion date | December 12, 2018 |
| Est. primary completion date | December 12, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU, Hôpital Claude Huriez | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | decreased intensity of pain in referred otalgia | diminution of the pain intensity numerical rating scale (NRS) | three weeks | |
| Secondary | neuropathic pain | diminution of the Neuropathic Pain Scale Inventory (NPSI) | Three weeks | |
| Secondary | Numeric rating Scale | referred otalgia after surgery: intensity | one, three and six months | |
| Secondary | Neuropathic Pain Symptom Inventory | referred otalgia after surgery: presence | one, three and six months |