None listed
Conditions
Brief summary
Hysteroscopy is often performed on patients while they are awake, while we try to make the procedure comfortable; a degree of pain is usually experienced. This study will be using a medication called methoxyflurane that is commonly used for pain relief for conscious procedures to see whether it is useful for women having hysteroscopies. We will be giving half our study participants an inhaler with methoxyflurane, and another half will have an inhaler without the medication inside. We will then ask both groups questions about how they felt during the procedure and compare the two to see if all women should be offered methoxyflurane with their hysteroscopy.
Interventions
3ml of inhaled methoxyflurane will be given via a Penthrox inhaler over a 10 minute period while a patient has an outpatient/conscious hysteroscopy procedure. The medicine will be self-administered with supervision by a doctor and a nurse.
The fidelity of the administration will be maintained by 1. Uniform medication and placebo preparation within pre-packaged units containing a single inhaler and a 3ml vial of methoxyflurane. 2. The placebo will use the same pre-packaged unit, but instead of
3ml of inhaled methoxyflurane will be given via a Penthrox inhaler over a 10 minute period while a patient has an outpatient/conscious hysteroscopy procedure. The medicine will be self-administered with supervision by a doctor and a nurse. The fidelity of the administration will be maintained by 1. Uniform medication and placebo preparation within pre-packaged units containing a single inhaler and a 3ml vial of methoxyflurane. 2. The placebo will use the same pre-packaged unit, but instead of the methoxyflurane being poured into the inhaler, a few drops of the medication will be placed on the exterior surface to allow the prominent smell of the medication to contribute to blinding.
Sponsors
Waikato DHB
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Patients booked to our hysteroscopy clinic, these patients have already been assessed from gynaecology clinic as suitable candidates for awake/outpatient hysteroscopies. They will be invited to participate in the trial on the day of their hysteroscopy.
Exclusion criteria
Non-fluent English, known renal disease (Creatinine greater than or equal to 1.5 times the upper limit of normal), known liver disease (bilirubin greater than or equal to 2.5 times the upper limit of normal), known sensitivity to fluorinated anaesthetic, known cardiovascular disease, altered consciousness, personal history of malignant hyperthermia, family history of malignant hyperthermia unless personally tested to be negative,
Outcome results
None listed