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Trial registered on ANZCTR


Registration number
ACTRN12620000042943
Ethics application status
Approved
Date submitted
19/12/2019
Date registered
21/01/2020
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results information initially provided
21/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Rapid Administration of Methoxyflurane to patients in Emergency Department (ED) Study (RAMPED)
Scientific title
A Randomised Control Trial of Methoxyflurane vs Standard Care to assess the effect of the medication on the pain scores of patients at streaming
Secondary ID [1] 300138 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
RAMPED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 315668 0
Condition category
Condition code
Emergency medicine 313959 313959 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient is given a single dose of Methoxyflurane (3mL) via Inhaler device over 90 minutes, and the patient is assessed at set intervals during this time (at 15min, 30min, 60min and 90min since the commencement of medication) via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available.

Intervention adherence will be assessed by the patient self-reporting - if there is a issue with fidelity, the research assistant/data collector will report as such on the case report form (CRF) and encourage the patient verbally to improve adherence to protocol.
Intervention code [1] 316411 0
Treatment: Drugs
Comparator / control treatment
Standard Care
- Current management of patient includes giving simple analgesia such as Paracetamol or Ibuprofen
Control group
Active

Outcomes
Primary outcome [1] 322362 0
The primary outcome will be defined as the proportion of participants achieving significant pain reduction, as assessed by a patient reported score via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED.
Timepoint [1] 322362 0
30 minutes since time of administration
Secondary outcome [1] 378228 0
Assess the duration of the effect of methoxyflurane usage on pain scores
The patient reported score, obtained via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable) with all integers between 0 and 10 inclusive available, will be assessed at the analysis stage by plotting the progression of the pain scores over the timepoints.
Timepoint [1] 378228 0
15 minutes since time of administration
30 minutes since time of administration
45 minutes since time of administration
60 minutes since time of administration
90 minutes since time of administration
Secondary outcome [2] 378731 0
Assess if Methoxyflurane usage impacts upon the use of any other opioid analgesia in the ED
Data regarding the use of opioid analgesia is derived from the patient medical notes, and will be analysed against standard care use of opioids to assess differences in type, frequency and/or dose.
Timepoint [2] 378731 0
15 minutes since time of administration
30 minutes since time of administration
45 minutes since time of administration
60 minutes since time of administration
90 minutes since time of administration
Secondary outcome [3] 378736 0
Mean pain score, obtained via a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable) with all integers between 0 and 10 inclusive available
Timepoint [3] 378736 0
30 minutes since time of administration
Secondary outcome [4] 378737 0
The proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale
Timepoint [4] 378737 0
15 minutes since time of administration
30 minutes since time of administration
45 minutes since time of administration
60 minutes since time of administration
90 minutes since time of administration

Eligibility
Key inclusion criteria
- Adult patients (aged greater than or equal to 18 years, and less than or equal to 75 years)
- Presentation to ED from home or scene of incident
- Initial pain score of 8/10 or greater
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Interhospital transfers
- Haemodynamic instability (cardiovascular instability, respiratory depression, head injury or impaired conscious state) defined as vital sign measurements that would be within met call criteria (e.g. HR<40 or >140, SBP<90 or >180, RR< 6 or >36, GCS<14)
- Pain possibly due to acute coronary syndrome
- Patients presenting with headache
- Pregnant patients or patients currently breastfeeding
- Known renal/hepatic failure
- Hypersensitivity to fluorinated anaesthetics
- Malignant hyperthermia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15550 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 28919 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304575 0
Hospital
Name [1] 304575 0
The Alfred Hospital’s Emergency & Trauma Centre
Address [1] 304575 0
55 Commercial Rd, Melbourne VIC 3004
Country [1] 304575 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medical Developments International
Address
4 Caribbean Drive,
Scoresby, Vic, 3179, Australia
P.O. Box 9004,
Scoresby, Vic, 3179, Australia
Country
Australia
Secondary sponsor category [1] 304861 0
None
Name [1] 304861 0
Address [1] 304861 0
Country [1] 304861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305001 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 305001 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 305001 0
Australia
Date submitted for ethics approval [1] 305001 0
17/12/2018
Approval date [1] 305001 0
10/01/2019
Ethics approval number [1] 305001 0

Summary
Brief summary
The Alfred Hospital is an adult major trauma centre, and receives in excess of 65,000 patient presentations per year. This study is an open-label randomised controlled trial of one dose of Methoxyflurane (3mL) administered after streaming to eligible patients compared to standard care. The primary outcome will be defined as the proportion of participants achieving significant pain reduction. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. Secondary outcomes will be the mean pain score at 30 min, the proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale, and the use of any opioid analgesia. Participants will be asked to indicate the intensity of pain at 30, 60, and 90 min after administration of analgesia, with a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98922 0
Prof Biswadev Mitra
Address 98922 0
National Trauma Research Institute
85-89 Commercial Rd, Melbourne VIC 3004
Country 98922 0
Australia
Phone 98922 0
+61 03 9076 8806
Fax 98922 0
Email 98922 0
biswadev.mitra@monash.edu
Contact person for public queries
Name 98923 0
Prof Biswadev Mitra
Address 98923 0
National Trauma Research Institute
85-89 Commercial Rd, Melbourne VIC 3004
Country 98923 0
Australia
Phone 98923 0
+61 03 9076 8806
Fax 98923 0
Email 98923 0
biswadev.mitra@monash.edu
Contact person for scientific queries
Name 98924 0
Prof Biswadev Mitra
Address 98924 0
National Trauma Research Institute
85-89 Commercial Rd, Melbourne VIC 3004
Country 98924 0
Australia
Phone 98924 0
+61 03 9076 8806
Fax 98924 0
Email 98924 0
biswadev.mitra@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6238 0
Study protocol
Citation [1] 6238 0
Link [1] 6238 0
Email [1] 6238 0
biswadev.mitra@monash.edu
Other [1] 6238 0
Attachment [1] 6238 0
Type [2] 6239 0
Ethical approval
Citation [2] 6239 0
Link [2] 6239 0
Email [2] 6239 0
biswadev.mitra@monash.edu
Other [2] 6239 0
Attachment [2] 6239 0
Type [3] 6240 0
Clinical study report
Citation [3] 6240 0
Link [3] 6240 0
Email [3] 6240 0
biswadev.mitra@monash.edu
Other [3] 6240 0
Attachment [3] 6240 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary