Adjunct Sphenopalatine Ganglion Analgesia for Rapid Discharge (ASGARD) among emergency department patients with headache

INTERVENTION: 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 CONDITION: Emergency medicine ‐ Other emergency care Headache; ; Headache Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Current headache pain intensity[1‐item numerical rating scale (the scale spans 0–10 points with zero considered no pain and 10 considered the worst pain imaginable) Pre‐procedure, immediately post‐procedure, five minutes post‐procedure, 15 minutes post‐procedure, and 30 minutes post‐procedure (primary timepoint)] INCLUSION CRITERIA: ‐ Attending one of the three Eastern Health emergency departments (Angliss Hospital, Maroondah Hospital, or Bo XHill Hospital) ‐ Has a headache (pain located in the head, above the orbitomeatal line and/or nuchal ridge) ‐ Aged 18 years or greater SECONDARY OUTCOME: Adverse events[Any adverse events (any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have a causal relationship with this treatment) will be manually extracted from patient charts via the electronic medical record. All adverse events will be monitored and reported in line with National Health and Medical Research Council guidelines for clinical trials involving therapeutic goods. ; ; Risks associated with both the intervention (2% lidocaine) and comparator (saline) due to the insertion of a cotton‐tipped applicator into the nasal cavity include transient bad taste (common/minor), mild transient nausea due to mechanical stimulation (common/minor), transient watery eyes (common/minor), epistaxis (nosebleed; uncommon/minor), transient hypotension (uncommon/moderate), and infection (rare/severe). The intervention is also associated with throat/nasal numbness (common/minor), mild nausea due to lidocaine (common/minor), facial nerve irritation (rare/moderate), and allergic reaction (rare/severe). Discharge from emergency department] Clinician‐reported procedure satisfaction[1‐item 5‐point Likert scale (responses: very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, or very satisfied) 30 minutes post‐procedure] Patient‐reported procedure satisfaction[1‐item 5‐point Likert scale (responses: very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, or very satisfied) 30 minutes post‐procedure] Patient‐reported treatment allocation[1‐item question (responses: treatment or placebo) 30 minutes post‐procedure ] Re‐presentation within 72 hours[Re‐presentation to an Eastern Health emergency department within 72 hours (yes or no) will be manually extracted from patient charts via the electronic medical record 72 hours post‐discharge from emergency department] Time to discharge[Minutes from procedure completion to patient discharge (home or to the ward) will be manually extracted from patient charts via the electronic medical record Discharge from emergency department] Use of adjunct analgesia[Data on administration of adjunct analgesia (any pain relief medication other than that which the patient is randomised to receive) will be manually extracted from patient charts via the electronic medical record Discharge from emergency department] Use of intravenous therapy[Use of intravenous therapy (yes or no) will be manually extracted from patient charts via the electronic medical record Discharge from emergency department]