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Trial registered on ANZCTR


Registration number
ACTRN12617000345381
Ethics application status
Approved
Date submitted
25/02/2017
Date registered
6/03/2017
Date last updated
23/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Propofol on Trial for Headaches in the Emergency Department Setting
Scientific title
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
Secondary ID [1] 291277 0
Emergency Medicine Foundation: EMSS-320R26-2016-WOOD
Universal Trial Number (UTN)
U1111-1193-4899
Trial acronym
POTHEDS
Linked study record
not applicable

Health condition
Health condition(s) or problem(s) studied:
Refractory Headache 302225 0
Condition category
Condition code
Anaesthesiology 301824 301824 0 0
Pain management
Neurological 301891 301891 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297291 0
Treatment: Drugs
Comparator / control treatment
No comparator as this is a proof of concept trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301240 0
The first primary outcome is to measure the effect that a continuous infusion of no greater than 120mg of propofol over 40 minutes has on refractory migraine-like headaches and associated symptoms (composite). The outcome will be measured using an average 100mm visually aided scale (VAS) as well as associated symptoms of interest, including unilateral headache, pulsatile sensation, moderate or severe pain, avoidance of physical activity, nausea, vomiting, photophobia and phonophobia.
Timepoint [1] 301240 0
The scoring of headache pain utilizing a 100mm VAS will be recorded upon commencement of the infusion and at regular intervals of 20, 40 and 60 minutes. The presence or absence of associated symptoms (e.g., nausea, vomiting, photophobia etc.) will be recorded at the same time points. Headache pain will also be recorded at 24 and 48 hours in a follow-up phone call with each participant and will also inquire if the patient has returned to baseline function for routine daily activities.
Primary outcome [2] 301297 0
The second primary outcome is the proportion of patients that score no greater than 4 on the Ramsay Sedation Score (RSS) and no less than 13 on the Glasgow Coma Score (GCS). The bedside research nurse providing continuous observation and recording interval data sets should at no time for medical reasons be required to touch the participant.
Timepoint [2] 301297 0
Both the RSS and GCS will be recorded at regular intervals from the commencement of the infusion at 15, 30, 45 and 60 minutes
Primary outcome [3] 301298 0
The third primary outcome is measurement of any adverse outcomes or derangement of vital signs requiring intervention using continuous observation and interval data sets. Tests comprise continuous monitoring of participant heart rate, oxygen saturation, respiratory rate and end tidal CO2. Blood pressure will be recorded at regular intervals.
Timepoint [3] 301298 0
There will be continuous monitoring of heart rate, oxygen saturation, respiratory rate and end tidal CO2 for the duration of the 40 minute infusion. These vital signs will be recorded at regular intervals along with blood pressure from the commencement of the infusion at 15, 30, 45 and 60 minutes. Any of these continuously monitored vital signs that fall outside of a specified range will be recorded at that point in time as an adverse event.
Secondary outcome [1] 332094 0
A secondary outcome measure will be overall length of stay in the emergency department. This will be assessed using the time recorded at triage to time recorded at patient discharge point, which is logged on the Emergency Department Information System (EDIS).
Timepoint [1] 332094 0
Length of stay from time of triage to discharge time will be compared to the average length of stay for headaches not requiring medical work-up in the preceding 6 months. The lengths of stay for this treatment will understandably be artificially lengthened given the requirement for recruitment and extended consent.

Eligibility
Key inclusion criteria
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:
1. unilateral headache
2. pulsatile sensation
3. moderate to severe pain intensity
4. aggravated by or causing avoidance of routine physical activity
D. The headache should be associated with at least one of the following
1. nausea and/or vomiting
2. photophobia and/or phonophobia
E. Lastly the headache should not be attributable to another disorder.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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:
1. severe obstructive sleep apnoea requiring CPAP
2. myasthenia gravis
3. 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
on order of presentation and suitability for enrollment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
An opportunist sample of 30 participants will be recruited from adults aged between 18 and 60 presenting to either Redcliffe or Nambour Emergency Departments. Participants will have an acute or sub-acute migraine-like headache that has been refractory to standard oral therapeutic options. All participants will provide written informed consent prior to undertaking treatment, in accordance with the National Statement on Ethical Conduct in Human Research.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To assess the efficacy of treatment pain ratings utilizing a visually aided scale (VAS) at six time points of 0, 20, 40 and 60 minutes post administration, as well as 24 and 48 hours post-administration, will be collated and descriptive statistics (Mean, StDev) will be computed. A Mann-Whitney U test (for nonparametric sample) will be used to assess the difference between VAS ratings of headache pain before, during and after propofol administration in this group of patients. Furthermore the presence or absence of nausea, vomiting, photophobia, phonophobia and avoidance of physical activity pre and post administration will be recorded.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/04/2017
Actual
6/06/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
2/01/2019
Actual
Sample size
Target
30
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7563 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [2] 7564 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 15453 0
4020 - Redcliffe
Recruitment postcode(s) [2] 15454 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 295742 0
Hospital
Name [1] 295742 0
Redcliffe Hospital Private Practice Trust Fund
Country [1] 295742 0
Australia
Funding source category [2] 295743 0
Charities/Societies/Foundations
Name [2] 295743 0
Emergency Medicine Foundation
Country [2] 295743 0
Australia
Primary sponsor type
Individual
Name
Dr Erik Wood
Address
Redcliffe Hospital Emergency Department, Anzac Avenue, Redcliffe QLD 4020
Country
Australia
Secondary sponsor category [1] 294585 0
None
Name [1] 294585 0
Address [1] 294585 0
Country [1] 294585 0
Other collaborator category [1] 279444 0
Individual
Name [1] 279444 0
Dr Ogilvie Thom
Address [1] 279444 0
Nambour General Hospital Emergency Department, Hospital Road, Nambour QLD 4560
Country [1] 279444 0
Australia
Other collaborator category [2] 279445 0
Individual
Name [2] 279445 0
Dr Julia Hocking
Address [2] 279445 0
Emergency Medicine Foundation, 2/15 Lang Parade, Milton QLD 4064
Country [2] 279445 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297042 0
The Prince Charles Hospital Human Research Ethics Committee (HRC)(EC00168)
Ethics committee address [1] 297042 0
Ethics committee country [1] 297042 0
Australia
Date submitted for ethics approval [1] 297042 0
07/09/2016
Approval date [1] 297042 0
08/02/2017
Ethics approval number [1] 297042 0
HREC/16/QPCH/286

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72786 0
Dr Erik Wood
Address 72786 0
Redcliffe District Hospital
Emergency Department
Ground Floor, Anzac Avenue
Redcliffe QLD 4020
Country 72786 0
Australia
Phone 72786 0
+61 (4) 1273 0459
Fax 72786 0
+61 (7) 3883 7412
Email 72786 0
erik.wood@health.qld.gov.au
Contact person for public queries
Name 72787 0
Erik Wood
Address 72787 0
Redcliffe District Hospital
Emergency Department
Ground Floor, Anzac Avenue
Redcliffe QLD 4020
Country 72787 0
Australia
Phone 72787 0
+61 (4) 1273 0459
Fax 72787 0
+61 (7) 3883 7412
Email 72787 0
erik.wood@health.qld.gov.au
Contact person for scientific queries
Name 72788 0
Erik Wood
Address 72788 0
Redcliffe District Hospital
Emergency Department
Ground Floor, Anzac Avenue
Redcliffe QLD 4020
Country 72788 0
Australia
Phone 72788 0
+61 (4) 1273 0459
Fax 72788 0
+61 (7) 3883 7412
Email 72788 0
erik.wood@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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