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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000624381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
5/05/2026
Date registered
Help: Date registered
21/05/2026
Date last updated
Help: Date last updated
24/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
21/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Adjunct Sphenopalatine Ganglion Analgesia for Rapid Discharge (ASGARD) among emergency department patients with headache
Scientific title
Effects of adjunct sphenopalatine ganglion block on pain intensity among emergency department patients with headache: a multicentre, individually randomised, double-blind, placebo-controlled, two-group parallel, superiority trial
Additional trial identifiers [1] 317200 0
Nil
Universal Trial Number (UTN)
Trial acronym
ASGARD
Related trial records

Health condition
Health condition(s) studied:
Headache 341744 0
Condition category
Condition code
Emergency medicine 337815 337815 0 0
Other emergency care
Neurological 338013 338013 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention description:
Usual care PLUS sphenopalatine ganglion block.

Usual care for tension headache is defined as follows:
- Paracetamol 1,000 mg 6 hourly; add in Ibuprofen 400 mg 6–8 hourly; use Oxycodone 5–10 mg for breakthrough pain.

Usual care for migraine headache is defined as follows:
- Rest in the quietest area available, darkened room and to avoid movement or any activity. Sleep will relieve symptoms.
- Pain relief with soluble nonsteroidal anti-inflammatory drug as early as possible (gastric stasis in migraine).
- Aspirin soluble 600–900 mg orally, repeat in 4 hours if required (avoid under 16 yrs).
- Paracetamol soluble 1,000 mg orally, 4-hourly, up to a maximum dose of 4,000 mg daily.
- Antiemetic drugs may improve absorption of analgesic drugs and may also reduce migraine pain by other mechanisms that are poorly understood.
- Metoclopramide 10–20 mg orally OR Prochlorperazine (Stemetil) 5–10 mg orally OR Prochlorperazine (Stemetil) 12.5 mg intravenous or with 1000 ml saline.
- Evidence suggests that intravenous prochlorperazine (Stemetil) is a safer option than intravenous chlorpromazine (Largactil) for migraines (due to its lower potential to cause refractory hypotension).
- If the patient has been treated with a nonsteroidal anti-inflammatory drug or simple analgesic and there is no improvement after 1–2 hours, or if this treatment has failed in previous attacks, then a triptan at the lower recommended dose can be used.
- Sumatriptan 50–100 mg orally, up to 300 mg in any 24-hour period.
- If the lower dose of the triptan is tolerated but ineffective, the higher dose can be used in subsequent attacks.
- Patients with vascular or coronary artery disease or uncontrolled hypertension should not use a triptan.
- Patients with risk of serotonin toxicity due to other drugs which raise serotonin should not use a triptan.
- Avoid opiates, usually worsen nausea and drowsiness.

Usual care for cluster headaches is defined as follows:
- High flow oxygen.
- Intranasal cophenylcaine spray.
- Sumatriptan: migraine medication, may be useful if taken early.
- Refer to medical/neurological outpatients for follow-up.
- Steroids and ergotamines are used for prevention.

Sphenopalatine ganglion block administration will be conducted as follows:
1. The patient will be placed in a comfortable supine or seated position.
2. The cotton-tipped applicator will be soaked in 0.3 mL of a 2% lidocaine solution.
3. The cotton-tipped applicator will be advanced into the nares parallel to the zygoma, with the tip angled laterally until it lays on the nasopharyngeal mucosa posterior to the middle nasal turbinate.
4. The cotton-tipped applicator will be left in position for five minutes.
5. The cotton-tipped applicator will be removed.

Delivery personnel:
The procedure will be conducted by emergency clinicians who have received training to administer the treatment.

Delivery configuration:
The procedure will be carried out face-to-face.

Frequency and timing of delivery:
The clinician will insert the applicator, leaving it in position for five minutes before removal.

Delivery location:
The intervention will be conducted at three emergency departments (Angliss Hospital: 40,107 total presentations per year, Box Hill Hospital: 63,687 total presentations per year, and Maroondah Hospital: 49,127 total presentations per year.

Adherence:
Adherence will be guaranteed by the emergency clinicians administering the treatment.
Intervention code [1] 333933 0
Treatment: Drugs
Description of the comparator or control
The control group will receive usual care as defined above PLUS administration of a placebo. The placebo procedure will be identical to the interventional procedure described above, except for the fact that the lidocaine solution will be replaced with saline.
Control group
Placebo

Outcomes
Primary outcome [1] 345269 0
Current headache pain intensity
Timepoint [1] 345269 0
Pre-procedure, immediately post-procedure, five minutes post-procedure, 15 minutes post-procedure, and 30 minutes post-procedure (primary timepoint)
Secondary outcome [1] 461280 0
Patient-reported procedure satisfaction
Timepoint [1] 461280 0
30 minutes post-procedure
Secondary outcome [2] 461281 0
Patient-reported treatment allocation
Timepoint [2] 461281 0
30 minutes post-procedure
Secondary outcome [3] 461282 0
Clinician-reported procedure satisfaction
Timepoint [3] 461282 0
30 minutes post-procedure
Secondary outcome [4] 461283 0
Use of intravenous therapy
Timepoint [4] 461283 0
Discharge from emergency department
Secondary outcome [5] 461285 0
Time to discharge
Timepoint [5] 461285 0
Discharge from emergency department
Secondary outcome [6] 461286 0
Use of adjunct analgesia
Timepoint [6] 461286 0
Discharge from emergency department
Secondary outcome [7] 461287 0
Re-presentation within 72 hours
Timepoint [7] 461287 0
72 hours post-discharge from emergency department
Secondary outcome [8] 461288 0
Adverse events
Timepoint [8] 461288 0
Discharge from emergency department

Eligibility
Key inclusion criteria
- Attending one of the three Eastern Health emergency departments (Angliss Hospital, Maroondah Hospital, or Box Hill Hospital)
- Has a headache (pain located in the head, above the orbitomeatal line and/or nuchal ridge)
- Aged 18 years or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Likely cause of headache is deemed serious (e.g. subarachnoid haemorrhage, subdural haematoma, cerebral venous sinus thrombosis, infection, tumour, stroke, temporal arteritis, glaucoma, hypertensive emergencies, carbon monoxide inhalation, pseudotumour cerebri, carotid/vertebral dissection, and reversible cerebral vasoconstriction syndromes)
- Inability to give informed consent
- Known allergy to lidocaine or amide-type local anesthetic
- Facial or sinus trauma/surgery within the past six weeks
- Active nasal infection
- Currently medicated with anticoagulants
- Prescribed intravenous therapy prior to enrolment
- Known hypersensitivity, allergy, or clinically significant adverse reaction to parabens (including methylparaben or propylparaben)
- Previous enrolment in the current study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The REDCap Randomisation Module, configured with restricted access to only unblinded investigators, will ensure allocation concealment. Upon confirmation of eligibility and consent within REDCap, the patient will be allocated a unique study code that corresponds to a pre-prepared vial that facilitates exposure to the intervention or comparator. Vials will be visually identical bar the aforementioned unique study code label, and will be pre-prepared by an investigator without contact with patients or clinicians. Vials will be securely stored at the three emergency departments in line with current secure Eastern Health storage policies for local anaesthetic.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomly assigned (1:1) using block randomisation with random block lengths (between 2 and 6 per block) to either intervention or comparator. An investigator without contact with patients or clinicians will generate the randomisation sequence using Stata (v19, StataCorp, College Station, United States of America). The same investigator will then upload the emanating CSV file to a REDCap electronic data capture tool hosted at Eastern Health.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics

Descriptive statistics will be summarised using frequencies and proportions, means and standard deviations, and medians and interquartile ranges where appropriate.

Primary and secondary outcomes

Patient will be the unit of analysis. An intention-to-treat approach and a of 0.05 will be adopted for all analyses. Separate linear (restricted maximum likelihood estimation) and logistic (maximum likelihood estimation via mean-variance adaptive Gauss-Hermite quadrature) mixed models with random effects for site (emergency department) and patient (nested within site) will evaluate between-group (intervention and comparator) estimated marginal effects with 95% confidence interval in primary and secondary outcomes. Sensitivity analyses will consider covariates (e.g. demographics and adjunct analgesia).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
2/06/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29472 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [2] 29473 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 29474 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 45790 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [2] 45791 0
3135 - Ringwood East
Recruitment postcode(s) [3] 45792 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 321745 0
Government body
Name [1] 321745 0
Eastern Health Foundation
Country [1] 321745 0
Australia
Primary sponsor type
Government body
Name
Eastern Health
Address
Country
Australia
Secondary sponsor category [1] 324585 0
None
Name [1] 324585 0
Address [1] 324585 0
Country [1] 324585 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320292 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 320292 0
Ethics committee country [1] 320292 0
Australia
Date submitted for ethics approval [1] 320292 0
27/01/2026
Approval date [1] 320292 0
18/03/2026
Ethics approval number [1] 320292 0
E26-002-125690

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149986 0
A/Prof Patrick J Owen
Address 149986 0
Eastern Health Emergency Medicine Program, Box Hill Hospital, 8 Arnold Street, Box Hill VIC 3128
Country 149986 0
Australia
Phone 149986 0
+61 03 99756049
Fax 149986 0
Email 149986 0
[email protected]
Contact person for public queries
Name 149987 0
Patrick J Owen
Address 149987 0
Eastern Health Emergency Medicine Program, Box Hill Hospital, 8 Arnold Street, Box Hill VIC 3128
Country 149987 0
Australia
Phone 149987 0
+61 03 99756049
Fax 149987 0
Email 149987 0
[email protected]
Contact person for scientific queries
Name 149988 0
Patrick J Owen
Address 149988 0
Eastern Health Emergency Medicine Program, Box Hill Hospital, 8 Arnold Street, Box Hill VIC 3128
Country 149988 0
Australia
Phone 149988 0
+61 03 99756049
Fax 149988 0
Email 149988 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.