Clinical trial NCT05729503: Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals
Official title: SPG Block Versus Placebo to Manage Anxiety at Electronic Dance Music Festivals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Anxiety
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn about the effect of a sphenopalatine ganglion (SPG) block in anxious patients at electronic dance music festivals. The main question is:

- Is an SPG block useful in reducing anxiety, in comparison to placebo?

Participants will have lidocaine-soaked cotton tip applicator placed inside each nare for 10-minutes, or have a saline-soaked cotton tip applicator placed inside each nare for 10-minutes.

Researchers compare the lidocaine-soaked intervention (SPG block) with the saline-soaked intervention (placebo) to see if it reduces anxiety in patients presenting at electronic dance music festivals with anxiety.

Detailed description: 1. Background \& Rationale

   Electronic dance music festivals are a growing source of entertainment in Canada. Attended by thousands at a time, it is important to have a medical team onsite to manage clinical issues in these mass gatherings. One of the most common clinical presentations at these festivals is anxiety. In a low-resource setting, it is not always possible to supply all guests with oral or injectable anti-anxiety therapy. Additionally, anti-anxiety medication is often sedating, which we would want to avoid in a patient population at higher risk of sedation (e.g., intoxication). A simple, non-sedating, alternative treatment that can be administered by a medical team member that can be given without the need of a needle would be ideal.

   Anecdotal reports have noted that sphenopalatine ganglion (SPG) blocks with lidocaine, intranasally, is effective for the relief of anxiety. As well, the PI has had anecdotal success in managing patient anxiety with SPG blocks. At the time of writing, there has been no published study found by our team to evaluate the efficacy of SPG blocks on anxiety.
2. Research Question \& Objectives

   Question: In electronic dance music festival attendees, who present with anxiety to the medical team, how does a 2% lidocaine-soaked cotton tip applicator, inserted into both nares until it meets resistance, compare with a saline-soaked cotton tip applicator, inserted into both nares until it meets resistance, for self-reported anxiety 10-minutes post-intervention?

   The objective of this trial is to study the effectiveness of bilateral SPG block for anxiety.
3. Methods

All individuals, who present with anxiety to the main medical area at electronic dance music festivals in Canada, will be recruited until sample size reaches at least 70 people. Inclusion criteria will include festival attendees aged 18+ with a complaint of anxiety. Exclusion criteria will include known allergy to lidocaine (standard practice involves medical team members asking patients what allergies they have), inability to pass a cotton tip applicator through the nares (e.g., obstruction), inability to report level of anxiety, or already have taken an anti-anxiety medication (e.g., lorazepam, midazolam).

After obtaining consent, participants will be randomized into two study arms using a random number generator. Arm 1 will receive an intranasal SPG block with 2% lidocaine in each nare, applied with long cotton tip applicators. Arm 2 will receive a long cotton tip applicator soaked with saline, inserted in each nare (placebo). The cotton tip applicators will remain in the nares for 10 minutes before removal.

After randomization, participants will be asked to rate their anxiety on a numeric response scale (0 to 10, where 0 is no anxiety and 10 is "worst anxiety imaginable") prior to receiving their assigned intervention. 10-minutes following intervention, participants will be asked to rate their anxiety once more.

Eligibility criteria: Inclusion Criteria:

* Festival attendees aged 18+
* A complaint of anxiety of at least 1 on a scale of 0 to 10 (11-point scale, where 0 represents "no anxiety" and 10 represents "worst anxiety imaginable").

Exclusion Criteria:

* Known allergy to lidocaine (standard practice involves medical team members asking patients what allergies they have; we will not directly ask about lidocaine in order to keep participants blinded to interventions)
* Inability to insert cotton tip applicator through the nares (e.g., distorted nasal anatomy, active nosebleed, obstructed nasal passages)
* Inability to verbally report level of anxiety
* Prior administration of an oral or intravenous anti-anxiety medication (e.g., lorazepam, midazolam) by festival medical staff since arrival at the festival (would confound treatment effect)

Primary outcomes:
measure: Patients' self-reported anxiety scores post-intervention
timeFrame: 10-minutes post-intervention
Secondary outcomes:
measure: Use of rescue-medication (i.e., oral/intravenous anti-anxiety medication)
timeFrame: 10-minutes post-intervention
measure: Improvement of headache
timeFrame: 10-minutes post-intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Electronic Dance Music festivals in Calgary
city: Edmonton
country: Canada
facility: Electronic Dance Music festivals in Edmonton
city: Toronto
country: Canada
facility: Electronic Dance Music festivals in Toronto
city: Vancouver
country: Canada
facility: Electronic Dance Music festivals in Vancouver
Study officials:
affiliation: University of Calgary
name: Anthony V Seto, MD
role: PRINCIPAL_INVESTIGATOR
References: