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临床试验/NCT05729503
NCT05729503撤回2 期

SPG Block Versus Placebo to Manage Anxiety at Electronic Dance Music Festivals

University of Calgary4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年5月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
入组人数
70
试验地点
4
主要终点
Patients' self-reported anxiety scores post-intervention

研究概览

简要总结

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.

详细描述

  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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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").

排除标准

  • 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)

研究组 & 干预措施

2% Lidocaine

Experimental

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

干预措施: Lidocaine 2% Injectable Solution (Drug)

Placebo

Placebo Comparator

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

干预措施: Placebo (Drug)

结局指标

主要结局

Patients' self-reported anxiety scores post-intervention

时间窗: 10-minutes 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.

次要结局

  • Improvement of headache(10-minutes post-intervention)
  • Use of rescue-medication (i.e., oral/intravenous anti-anxiety medication)(10-minutes post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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