Propofol for Migraine Treatment in Emergency Department

What: Intravenous Propofol infusion - Maximum of 1mg/kg and will be stopped short if the desired effect is achieved with a smaller dose - Slow infusion over 1 minute - Intravenous Infusion Why: A series of small studies and case reports have shown rapid relief of both chronic and acute migraine headache using Propofol, a lipid soluble short-acting intravenous anaesthetic. It seems that the therapeutic effects of Propofol are due to its agonistic effects on the chloride channels in the ß1 subunit of GABA receptors, in addition to its inhibition of afferent sympathetic action and cardiac baroreceptor reflexes. As a result, propofol’s anaesthetic effects on the central nervous system may diminish the central sensitisation causing allodynia and hyperalgesia, (key steps in the pathophysiological development of migraine) attributing to its mechanism of pain relief in migraine patients. Additionally, when Propofol has been safely administered at a sedative dosing, in migraine patients presenting to emergency department (in a case series) has shown rapid pain relief as well as a considerably reduced Length of Stay (LOS) in emergency department. Who: Migraine patients assessed as meeting the inclusion criteria, with no exclusion criteria, will be consented by site investigator or designee for the patient’s participation in the study. Patients may be administered with 1000ml of normal saline if the treating clinician is concerned about the patient’s hydration level. All enrolled patients will be randomised to receive either the test or the control treatment. The site investigator must follow the appropriate hospital protocols for procedural sedation and treat with up to 1mg/kg intravenous Propofol. Patients receiving Propofol therapy will be transferred to the resuscitation bay with one:one nursing care during the sedation, as is standard practice for all procedural sedations performed in the emergency departments. How: The drug will be administered as a slow infusion over 1 minute through a peripheral intravenous line with a 10 mL syringe until the patient falls asleep without a rise in end-tidal CO2 or a decrease in respiratory rate or oxygen saturation. The maximum dose of Propofol allowed is 1 mg/kg and will be stopped short if the desired effect is achieved with a smaller dose. Where: Patients receiving Propofol therapy will be transferred to the resuscitation bay, placed on a cardiac monitor, provided supplemental oxygen by nasal cannula, end-tidal CO2 monitor, with one:one nursing care during the sedation, as is standard practice for all procedural sedations performed in the emergency departments. When and how much: The drug will be administered as a slow infusion over 1 minute through a peripheral intravenous line with a 10 mL syringe until the patient fell asleep without a rise in end-tidal CO2 or a decrease in respiratory rate or oxygen saturation. The maximum dose of Propofol allowed is 1 mg/kg and will be stopped short if the desired effect is achieved with a smaller dose. The patients will be allowed to sleep until they wake up on his or her own. After the patient is arousable, and patient’s condition must be monitored. Tailoring: Patients may be administered with 1000ml of normal saline if the treating clinician is concerned about the patient’s hydration level. In the unlikely event that The Alfred Hospital is of the opinion that any aspect of the study protocol creates an immediate hazard to a trial patient, he or she may implement a deviation from or change to the protocol without prior approval from the Alfred Health Human Ethics Committee. The implemented deviation or change must be reported in a protocol deviation form and reported to the site principal investigator and Alfred Health Human Ethics Committee.