RecruitingPhase 1ACTRN12617000345381

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


Sponsor

Dr Erik Wood

Enrollment

30 participants

Start Date

Jun 6, 2017

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing low-dose propofol (an anaesthetic medication) as a treatment for severe migraines that are not responding to usual medications in the emergency department. The idea is that a slow infusion of propofol at a low dose may quickly relieve stubborn migraine pain without the long wait times associated with other treatments. You may be eligible if: - You are between 18 and 60 years of age - You are in the emergency department with a migraine-like headache lasting 2–72 hours that is not responding to standard treatment - You have had at least 3 similar headaches before - Your headache has features such as being one-sided, throbbing, moderate to severe, and associated with nausea or light/sound sensitivity You may NOT be eligible if: - You are pregnant - You weigh more than 110 kg - You have an allergy to propofol or lignocaine - This is your first-ever headache - Your headache came on suddenly and was the worst of your life - You have neck stiffness, neurological symptoms, recent head trauma, or a shunt in your brain - You have taken opioid pain medication (other than codeine) or sedatives in the last 6 hours Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Th

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)

Redcliffe Hospital - Redcliffe

QLD, Australia

Nambour General Hospital - Nambour

QLD, Australia

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ACTRN12617000345381