Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals

NCT05729503 | Withdrawn Phase 2

• 1 other identifier: REB23-0181
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Patients' self-reported anxiety scores post-intervention

  Patients will rate their anxiety on an 11-point scale (0 = "no anxiety", 10 = "worst anxiety imaginable"). The lowest score is 0 and the highest score is 10. Lower scores indicate better outcome.

  10-minutes post-intervention

Secondary Outcomes (2)

• Use of rescue-medication (i.e., oral/intravenous anti-anxiety medication)

  10-minutes post-intervention

• Improvement of headache

  10-minutes post-intervention

Study Arms (2)

2% Lidocaine

EXPERIMENTAL

1 cotton tip applicator, pre-soaked in 2% lidocaine, inserted into each nare, and left for 10 minutes

Drug: Lidocaine 2% Injectable Solution

Placebo

PLACEBO COMPARATOR

1 cotton tip applicator, pre-soaked in saline, inserted into each nare, and left for 10 minutes

Drug: Placebo

Interventions

Lidocaine 2% Injectable Solution DRUG

Cotton tip applicator pre-soaked with lidocaine

Also known as: Lidocaine

2% Lidocaine

Placebo DRUG

Cotton tip applicator pre-soaked with saline

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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").

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (4)

Electronic Dance Music festivals in Calgary

Calgary, Canada

Location

Electronic Dance Music festivals in Edmonton

Edmonton, Canada

Location

Electronic Dance Music festivals in Toronto

Toronto, Canada

Location

Electronic Dance Music festivals in Vancouver

Vancouver, Canada

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Lidocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anthony V Seto, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: May 6, 2026
• Primary Completion: May 6, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)