None listed
Conditions
Brief summary
Headache is a common reason for seeking emergency care in Australia. The sphenopalatine ganglion represents a promising anatomical target for analgesic intervention among patients with headache. Findings from the seven studies conducted to date support that a sphenopalatine ganglion block may be effective among emergency department patients with headache. This multicentre (Angliss Hospital, Box Hill Hospital, and Maroondah Hospital), individually randomised, double-blind, placebo-controlled, two-group parallel (1:1), superiority trial will examine the effectiveness of an adjunct sphenopalatine ganglion block in adult emergency department patients with headache. We hypothesise that an adjunct sphenopalatine ganglion block will be superior to placebo for all outcomes.
Interventions
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.
Sponsors
Study design
Eligibility
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
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