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Trial registered on ANZCTR


Registration number
ACTRN12620000810910
Ethics application status
Approved
Date submitted
22/06/2020
Date registered
13/08/2020
Date last updated
13/08/2020
Date data sharing statement initially provided
13/08/2020
Date results information initially provided
13/08/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Methoxyflurane analgesia for outpatient intrauterine device insertion
Scientific title
Methoxyflurane for intrauterine device insertion in conscious patients, an open, single arm pilot study testing feasibility and medication acceptability
Secondary ID [1] 301586 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MIDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intrauterine device insertion 317959 0
Pain relief 317960 0
Condition category
Condition code
Reproductive Health and Childbirth 315994 315994 0 0
Contraception
Anaesthesiology 315995 315995 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 4, open, single centre, single arm pilot study of methoxyflurane inhalation during outpatient intrauterine device insertion.

30 participants will be offered one dose of 3ml methoxyflurane via a Penthrox inhaler. It is self-administered under the supervision of a clinician. The duration of the administration is 10 minutes or less.
Intervention code [1] 317887 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324199 0
Patient reported acceptability via 5-point likert scales.
Patient acceptance (re: the use of methoxyflurane for outpatient hysteroscopy): Completely acceptable, mostly acceptable, somewhat acceptable, mostly unacceptable, completely unacceptable
Timepoint [1] 324199 0
Immediately following their procedure.
Primary outcome [2] 324705 0
Would the patient have the medication in the same situation again? Definitely yes, maybe yes, maybe no, definitely no, do not know.
Timepoint [2] 324705 0
Immediately following the procedure
Secondary outcome [1] 384006 0
Patient perceived pain levels during IUD insertion and 15 mins post procedure using a 0-100mm visual analog scale,
Timepoint [1] 384006 0
Immediately following the procedure then 15 minutes afterwards.
Secondary outcome [2] 384007 0
The participants were informed the more common side effects in the participant information and consent form.
Participants were asked to report verbally about their side effects. These were recorded freestyle.
Timepoint [2] 384007 0
Immediately following IUD insertion
Secondary outcome [3] 384009 0
Cervical shock events were reported via a standardised question on the questionnaire: "Was there cervical shock? (Systolic blood pressure <80 or diastolic blood pressure <50 or heart rate <50 or unconsciousness). Yes/No"
Timepoint [3] 384009 0
Up to 15 minutes post procedure.

Eligibility
Key inclusion criteria
Adults undergoing outpatient intrauterine device insertion
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking, had any contraindication to an IUD insertion including cervical disease, pregnancy, abnormal bleeding of unknown diagnosis, active pelvic inflammatory disease, or had a history of renal disease/impairment, a known hypersensitivity to fluorinated anaesthetics, a history of cardiovascular instability including patients on beta-blockers (as may cause hypotension), and a history of possible adverse events (AEs)/intolerance to methoxyflurane

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)
NIl
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We are reporting percentages for the Likert scales. The secondary outcomes regarding pain scores will use visual analog pain score means, standard deviations, medians and interquartile ranges. Side effects will be listed in percentages.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/12/2018
Date of last participant enrolment
Anticipated
Actual
23/01/2019
Date of last data collection
Anticipated
Actual
23/01/2019
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16955 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 30612 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 306015 0
Hospital
Name [1] 306015 0
The Royal Women's Hospital
Country [1] 306015 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Cnr Grattan and Flemington rds
Parkville
VIC
3052
Country
Australia
Secondary sponsor category [1] 306476 0
Commercial sector/Industry
Name [1] 306476 0
Medical Developments International
Address [1] 306476 0
4 Caribbean Dr, Scoresby VIC 3179, Australia
Country [1] 306476 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306249 0
The Royal Women's Hospital HREC
Ethics committee address [1] 306249 0
Cnr Grattan and Flemington Rds
Parkville
VIC
3052
Ethics committee country [1] 306249 0
Australia
Date submitted for ethics approval [1] 306249 0
11/12/2018
Approval date [1] 306249 0
20/12/2018
Ethics approval number [1] 306249 0
18/37

Summary
Brief summary
Pain during outpatient intrauterine device (IUD) insertion and fear of that pain are barriers to people selecting them as long term reversible contraceptives. Methoxyflurane is an inhaled pain relief medication which has widespread application in conscious surgical procedures. This is the first study to assess the acceptability of methoxyflurane for patients having outpatient IUD insertions.

Aims: Our hypothesis is that patients using methoxyflurane during their outpatient (awake) intrauterine device insertion would find the medication acceptable and would want to have it in the same situation again.

Materials and Methods: Open, single-centre, single arm pilot study. 30 participants and their clinicians completed questionnaires at the time of their IUD insertion.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103238 0
Dr Emily Twidale
Address 103238 0
Waikato District Health Board
Hamilton Hospital
Elizabeth Rothwell Building
Level B2,
Selwyn st,
Hamilton
3024
Waikato
Country 103238 0
New Zealand
Phone 103238 0
+64 273193026
Fax 103238 0
nil
Email 103238 0
[email protected]
Contact person for public queries
Name 103239 0
Emily Twidale
Address 103239 0
Waikato District Health Board
Hamilton Hospital
Elizabeth Rothwell Building
Level B2,
Selwyn st,
Hamilton
3024
Waikato
Country 103239 0
New Zealand
Phone 103239 0
+64 273193026
Fax 103239 0
nil
Email 103239 0
[email protected]
Contact person for scientific queries
Name 103240 0
Emily Twidale
Address 103240 0
Waikato District Health Board
Hamilton Hospital
Elizabeth Rothwell Building
Level B2,
Selwyn st,
Hamilton
3024
Waikato
Country 103240 0
New Zealand
Phone 103240 0
+64 273193026
Fax 103240 0
nil
Email 103240 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing not included in ethics approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8287Ethical approval    380045-(Uploaded-21-06-2020-17-47-25)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.