Clinical trial

Involvement of the Sphenopalatine Ganglion in Cold Induced Headaches

Name

IRB-2023-398

Description

The primary objective of this study is to determine if a sphenopalatine ganglion (SPG) block, performed through intranasal atomization of 4% lidocaine, is able to prevent cold induced cephalgia ("Brain Freeze"). Secondary objectives will be to determine the degree of decreased pain/duration of brain freeze after sphenopalatine ganglion block

Trial arms

Trial start

2024-08-01

Estimated PCD

2024-11-01

Trial end

2024-12-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Lidocaine Topical 4% Topical Solution

Intranasal administration

Arms:

Intervention Arm

Bitrex

Bittering agent

Arms:

Placebo Arm

normal saline

Placebo

Arms:

Placebo Arm

Size

Primary endpoint

Does sphenopalatine ganglion (SPG) block prevent cold induced cephalgia

5 months

Eligibility criteria

Inclusion Criteria: * Wright State University Emergency Medicine (EM) resident physicians and Wright State Boonshoft School of Medicine medical students * Over the age of 18 years * Has gotten at least one brain freeze in their life Exclusion Criteria: * Individuals who have never gotten a brain freeze * Anyone who has had any sort of prior trauma to their oro- or nasopharynx or surgery on their oro- or nasopharynx, not to include dental surgery. * Pregnant patients * History of allergy to local anesthetic

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'All besides PI', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-06-05

1 organization

2 products

1 drug

4 indications

Organization

Wright State University

Product

Lidocaine

Indication

Headache