None listed
Conditions
Brief summary
We hypothesise that methoxyflurane (MOF) results in non inferior pain scores on a VAS compared to nitrous oxide50%/oxygen 50% (NO2) when used by patients undergoing TVOR with conscious sedation. Both agents are proven to be effective for procedural analgesia, with good safety profiles and tolerability. While comparisons of both have been made in the settings of emergency and out of hospital medicine, no studies have assessed the two for effectiveness during TVOR. While both agents are available for use in our unit, our routine protocol used for the majority of patients calls for NO2. However benefits of MOF include portability, single use inhaler device and potentially less concern regarding occupational exposure. We therefore plan an randomised control trial to test the efficacy. In fertility, it is important to consider potential effects of any medication used on lab outcomes, which will be considered in the secondary outcomes of the study.
Interventions
Assessing the effectiveness of self administered inhaled methoxyflurane 99.9% (3ml inhalation chamber device) versus Nitrous oxide 50%/ Oxygen 50% in providing procedural analgesia for patients undergoing trans vaginal oocyte retrieval. Patient will be given the allocated inhaled analgesia after identification checks have been completed, and a minimum of 1 minute prior to the start of the procedure, with inhalation ending immediately after the procedure is completed. The average time of transvag
Assessing the effectiveness of self administered inhaled methoxyflurane 99.9% (3ml inhalation chamber device) versus Nitrous oxide 50%/ Oxygen 50% in providing procedural analgesia for patients undergoing trans vaginal oocyte retrieval. Patient will be given the allocated inhaled analgesia after identification checks have been completed, and a minimum of 1 minute prior to the start of the procedure, with inhalation ending immediately after the procedure is completed. The average time of transvaginal oocyte procedure is approximately 15-20 minutes. Adherance to the intervention will be monitored via audit of the operation note, with study assessors asked to denote on the operation note if there have been any issues with compliance during the procedure.
Sponsors
Dr Aine McNally Bogue
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 47 Years
Healthy volunteers
Yes
Inclusion criteria
Women undergoing Transvaginal Oocyte Retrieval (TVOR) at The Fertility Centre Liverpool (TFCL) who have consented to partake in the study.
Exclusion criteria
Women who have had previous adverse reaction or hypersensitivity to either agent, patients with contraindications to either medication including significant respiratory, renal or hepatic compromise, recent eye surgery using intraocular gas, patients who have taken part in the study previously and patients who request specific agents. Of note, at TFC, as a low cost, low risk clinic our protocol dictates we do not treat patients with significant co morbidities or severe endometriosis
Outcome results
None listed