CRANIAL-FACIAL PAIN TREATMENT: PROSPECTIC, RANDOMIZED, OPEN-LABEL STUDY ON TRANSNASAL NONSURGICAL BLOCKADE VERSUS PHARMACOLOGICAL THERAPY

Phase 1

Conditions: Cranial facial pain
Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

Registration Number: EUCTR2013-001795-38-IT

Lead Sponsor: AZIENDA PROVINCIALE PER I SERVIZI SANITARI DELLA PROVINCIA AUTONOMA DI TRENTO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 162

Inclusion Criteria

Patients who access the emergency room:
1. Anterior cranio-facial pain that does not pass the median line of the face: periorbital primary headache, trigeminal neuralgia, acute sinusitis, toothache.
2. Age> 18 years old
3. Ability to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 162
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 162

Exclusion Criteria

1. Age <18 years
2. known or suspected pregnancy
3. Inability to provide informed consent
4. Fever
5. Suspicion or certainty of neurological disease as a cause of pain / symptoms
6. Acute eye condition (glaucoma)
7. Headache onset thunderclap, patients with acquired immunodeficiency and concomitant new headache, headache arising during exercise or sexual activity, headache due to drug overuse, consumption of drugs or alcohol, chronic use of antidepressants, minor tranquilizers and more, patients followed by the Center for Mental Health, detainees and patients with proven or suspected pregnancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy in the short-term (1 hour after the treatments) between the intranasal sphenopalatin nonoperative ganglio blockade and standard pharmacological treatment recommended in the centre and pre-defined for the purposes of the requirements of the protocol for the therapy of facial cranial pain;Secondary Objective: To compare the efficacy at 30 minutes, 24-48 hours after the treatments between the intranasal sphenopalatin nonoperative ganglio blockade and standard pharmacological treatment recommended in the centre and pre-defined for the purposes of the requirements of the protocol for the therapy of facial cranial pain;Primary end point(s): Pain decrease of at least 75% according to the VAS score ;Timepoint(s) of evaluation of this end point: After 1 hour from the treatments

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pain decrease according to the VAS score <br>McGill Questionnaire Pain<br>Type and dosage of drugs assumed ;Timepoint(s) of evaluation of this end point: After 30 minutes and 24-48 hours form the treatment<br>