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Nasal spray could replace opioids for Post-Aneurysm headaches

NCT ID NCT07116408

Symptom relief Sponsor: Wright State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a numbing nasal spray can safely reduce severe headaches after a brain aneurysm bleed. About 20 adults in the ICU will receive the spray along with standard pain meds. Researchers will compare pain levels and opioid use before and after treatment to see if the spray helps without causing side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: • Patients aged 18 years or older who are being treated in the neurologic ICU for subarachnoid hemorrhage with Hunt and Hess scale of 0-3 (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms) and able to verbally report headache will be considered for inclusion in this study. Exclusion Criteria: * Patients under the age of 18 years of age. * Patients with an allergy to lidocaine. * Patients from all vulnerable groups. * Patients with Hunt and Hess scale score of 4-5. (Scale ranges from 0 to 5 with higher numbers indicating more severe symptoms.) * Patients who are not able to consent. * Mentally impaired patients that are unable to provide consent. * Patients that are prisoners. * Pregnant patients. Additionally, patients with contraindications to use of the Tx 360 device will be excluded. Contraindications include: * History of recurrent nose bleeds. * Nasal septal deformity such as cleft lip and palate, choanal atresia (narrowed nasal passages), atrophic rhinitis, rhinitis medicamentosa, septal perforation, nasal/midface trauma. * Recent nasal/sinus surgery * Presence of a bleeding disorder (eg., Von Willebrand's disease or hemophilia). * Severe respiratory distress. * Presence of angiofibroma, sinus tumor, or granulomatous disease of the nasopharynx. * Presence of nasal trauma. * Nasal congestion that has been present more than 10 days, high fever, or abnormal appearance of the nasal mucosa or mucus.

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage Aneurysm Headache headache disorder subarachnoid hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysmal subarachnoid hemorrhage (ASAH) Headache

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Miami Valley Hospital

    RECRUITING

    Dayton, Ohio, 45409, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.