None listed
Conditions
Brief summary
Acute migraine is a common and often debilitating condition for which people often seek treatment in Emergency Departments. A number of treatments have proven efficacy compared with placebo, including metoclopramide, prochlorperazine, chlorpromazine and sumatriptan. These drugs are reported to lead to headache resolution by 2 hours from initial treatment in about 60% of people. Recent observational studies have suggested that propofol, a sedative and anaesthetic agent, may lead to headache resolution (migraine and tension type headache) by one hour from initial treatment in about 80% of people. These studies have used regimens where incremental small doses of propofol (20 to 40mg) are given every 3 - 5 minutes until either the headache resolves, or a maximum dose of about 140mg has been given. The mechanism of action remains unclear. No studies to date have compared propofol with placebo in adults with acute migraine, which is important, since the placebo response has been reported in previous migraine trials to be up to 40% (although it is most often around 10%). If this study does demonstrate that propofol is significantly superior to placebo, then studies directly comparing propofol with other agents will be warranted.
Interventions
Propofol 200mg/20ml. The 200mg will be drawn up in to a 20ml syringe, the concentration being 10mg/ml. It will be administered in up to 6 intravenous boluses, with the initial bolus being 4 ml (40mg) and subsequent boluses being 2 ml (20mg), so that the maximum dosage will be 14 ml (140mg). Boluses will be administered 3 - 5 minutes apart depending on patient response, with administration ceasing if the headache is resolved (pain rating zero), if an unexpected adverse event occurs, or when th
Propofol 200mg/20ml. The 200mg will be drawn up in to a 20ml syringe, the concentration being 10mg/ml. It will be administered in up to 6 intravenous boluses, with the initial bolus being 4 ml (40mg) and subsequent boluses being 2 ml (20mg), so that the maximum dosage will be 14 ml (140mg). Boluses will be administered 3 - 5 minutes apart depending on patient response, with administration ceasing if the headache is resolved (pain rating zero), if an unexpected adverse event occurs, or when the maximum dose is reached. The amount given, and times of administration will be recorded.
Sponsors
Dandenong Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Acute migraine, 18 to 65 years of age, patient reported pain on arrival of severity of 4 or more on the 1 to 10 numerical rating scale.
Exclusion criteria
Any doubt about diagnosis of migraine for any reason, any associated head injury, any known intracranial pathology, systolic blood pressure less than100 mmHg, use of defined drugs in previous 4 hours (opioids, ergotamine, triptans, neuroleptics or antemetics other than ondansetron), known allergy to propofol, intralipid, egg or soy products. Migraine WITH aura comprising of neurological symptoms, aura being defined as: at least 2 of these, fully reversible aura symptoms: visual symptoms (flickering lights/spots/lines/visual loss) or Sensory symptoms (pins/needles/numbness), or Dysphasic speech disturbance; And at least 2 of these: Homonymous visual and/or unilateral sensory symptoms or at least one aura symptom developing over > 5 min, or Aura symptom(s) lasting between 5 and 60 minutes
Outcome results
None listed