Methoxyflurane analgesia for outpatient intrauterine device insertion

Methoxyflurane for intrauterine device insertion in conscious patients, an open, single arm pilot study testing feasibility and medication acceptability

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000810910

Acronym

MIDI

Enrollment

Registered

2020-08-13

Start date

2018-12-26

Completion date

2019-01-23

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

Adults undergoing outpatient intrauterine device insertion

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

Outcome results