Propofol on Trial for Headaches in the Emergency Department Setting
A proof of concept study assessing the safety and efficacy of continuous infusion dosing of a sub-anaesthetic dose of propofol for the treatment of refractory migraine-like headaches in the emergency department setting
Dr Erik Wood
30 participants
Jun 6, 2017
Interventional
Conditions
Summary
Headache is a common reason why patients present to the hospital emergency department. Often patients are presenting to hospital for the simple reason that they are experiencing a headache that is not responding to commonly available medications used to get rid of headaches. Unfortunately there is not good evidence to support which available hospital medications consistently offer effective pain relief to individuals with these types of refractory headache. Understandably this is a challenging scenario in the emergency department setting for both the patient and physician that often leads to inadequate or unsatisfactory symptom relief. However a few small trials to date have shown promising evidence that the medication propofol is potentially an effective, safe and quick treatment alternative for stubborn headaches. It is important to note that propofol is not a new medication and is routinely used on a daily basis throughout hospitals for both general anaesthesia and procedural sedation. It is the intention of this research project to demonstrate that infusing a low dose of this medication over a relatively short period of time is an effective new use for a familiar and already commonly utilised medication. This has the potential to introduce a new safe and effective treatment option for stubborn headaches that can significantly reduce treatment times by rapidly restoring patients to baseline levels of function and comfort. Furthermore it reduces overall lengths of stay in the emergency department and contributes to overall improved emergency department patient flow.
Eligibility
Inclusion Criteria12
- Adult ED patients presenting with a low risk aetiology acute or sub-acute migraine-like headache that is refractory to standard oral therapy in adult ED patients that meet the following criteria:
- A. At least 3 previous attacks similar to the current attack and fulfil criteria B-D.
- B. The current attack regardless of treatment has lasted longer than 2 hours and less than 72 hours.
- C. The headache meets at least 2 of the 4 following criteria:
- unilateral headache
- pulsatile sensation
- moderate to severe pain intensity
- aggravated by or causing avoidance of routine physical activity
- D. The headache should be associated with at least one of the following
- nausea and/or vomiting
- photophobia and/or phonophobia
- E. Lastly the headache should not be attributable to another disorder.
Exclusion Criteria28
- pregnant
- age <18 or > 60 years
- body weight > 110kg
- allergy to propofol or lignocaine
- employee of the hospital
- previously enrolled in the study
- intention to drive themselves home
- rapid onset of headache
- instantly peaking neck stiffness at time of onset of headache
- worst headache of patient’s life
- first occurrence of a headache
- significant change in a long-standing headache pattern
- precipitation of headache with the Valsalva manoeuvre (e.g. coughing, sneezing or bending)
- specific medical concerns:
- severe obstructive sleep apnoea requiring CPAP
- myasthenia gravis
- ventriculo-peritoneal shunt
- headache associated with trauma
- deranged vital signs [heart rate > 90, SBP < 100, temperature > 38.0C, oxygen saturations < 96%]
- objective focal neurological deficit
- seizure just preceding or since onset of headache
- behavioural disturbance
- history of altered level of consciousness defined as GCS<15
- anti-coagulation with warfarin, rivaroxiban, apixaban, dabigatran, clopidegrel or other pharmacologic equivalents
- self-administration of oral opioids (excluding codeine) or benzodiazepines within the last 6 hours prior to presentation to the ED
- intoxicated patient
- treatment in the emergency department with potentially sedating medications such as oral or intravenous opioids (excluding codeine), benzodiazepines or chlorpromazine
- ingestion or administration of medication(s) that may pose a cumulative sedative risk as per the discretion of the treating clinician
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Interventions
All patients will have an intravenous cannula placed for the treatment intervention. Pain or discomfort at the injection site is a recognised common side effect of propofol upon initial injection. Therefore as is common clinical practice in the anaesthetic environment, all intravenous cannula sites will be pre-treated with a single dose of 25mg or 2.5mL of intravenous lignocaine 1% to mitigate injection site discomfort secondary to propofol and to optimise patient comfort. Subsequently participants will receive the lesser dose of either 120mg or 2mg/kg (rounded to the nearest ten) of propofol. This means that participants weighing more than 55kg will receive 120mg of propofol and that participants weighing less than 55kg will receive an adjusted reduced dose of propofol. All doses of propofol will be infused over the same time period of 40 minutes and will be a single dose only. This calculates to no greater than 15mg or 1.5mL of propofol every 5 minutes.
Locations(2)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12617000345381