Sphenopalatine Ganglion Block & Cold Induced Headaches

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

This study will be performed in two phases. The first phase will include a pre-medicated phase where the subjects will be required to rapidly drink up to ½ of a 32 fluid oz icecold slushy to induce a brain freeze. The flavor will be chosen by the participants. The time to onset, intensity, location, and duration of the headache will be recorded. The second phase will commence when the subjects have returned to their normal pain free state, a minimum of 10 minutes has passed since the resolution of the first cold headache, and they feel ready to move to the next phase. The time from complete resolution of the brain freeze to the start of the second phase will be recorded. Any subject that wishes to drop out from the study at this time is free to do so. They may keep their drink and finish it at a more leisurely pace should they choose. Then the subjects will receive either 1 mL of 4% lidocaine (0.5mL in each nostril) administered by intranasal atomization or 0.9% normal saline administered by intranasal atomization. The normal saline placebo will be mixed with an edible bittering agent added to blind the participant from recognizing the taste of the lidocaine containing solution. Only participants that experienced a brain freeze in the first phase will be able to move onto the second phase. Each participant will then rapidly drink up to ½ of a 32 fluid oz ice-cold slushy to induce a brain freeze. The time to onset, intensity, location, and duration of the headache will be recorded. All pain scores will be recorded using a visual analog scale from 0-100 where 0 is no pain and 100 is the worst pain imaginable. We will also record any side effects that the subjects may experience during or shortly after the procedure. ;

Study Design

Related Conditions & MeSH terms

Headache

Clinical Trial Details

NCT number	NCT06310200
Study type	Interventional
Source	Wright State University
Contact	Dana E Schulz, DO
Phone	6317071796
Email	dana.schulz@wright.edu
Status	Not yet recruiting
Phase	Phase 1
Start date	April 1, 2024
Completion date	July 1, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sphenopalatine Ganglion Block and Cold Induced Headaches

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms