Methoxyflurane for Analgesia During Hysteroscopy

Summary

This study is to assess the non-inferiority of using inhaled methoxyflurane (MOF) versus intravenous conscious sedation with fentanyl and midazolam on women's perception of pain, during hysteroscopy and/or polypectomy in an outpatient setting. The researchers will determine whether the participants receiving the inhaled MOF (experimental group) achieve similar clinical effects in reduction of pain and ability to complete the procedure. Women's perception of pain will be recorded on a scale from 0 to 10 using the numeric rating scale (NRS).

Timeline

Start

2025-06-01

Primary completion

2025-12-31

Completion

2026-01-30

Publications

• Background 1. Penthrox product monograph. Paladin Labs Inc, 100 Alexis-Nihon Blvd, Suite 600, St-Laurent, Quebec, Canada.
• Background Jephcott C, Grummet J, Nguyen N, Spruyt O. A review of the safety and efficacy of inhaled methoxyflurane as an analgesic for outpatient procedures. Br J Anaesth. 2018 May;120(5):1040-1048. doi: 10.1016/j.bja.2018.01.011. Epub 2018 Feb 12.
• Background Debuka E, Birkenhead P, Shah S, Narayan B, Giotakis N, Thorpe P, Graham SM, Fischer BE, Peterson N. Penthrox(R) (Methoxyflurane) as an Analgesic for Removal of Circular External Fixators and Minor Procedures during the COVID-19 Pandemic. Strategies Trauma Limb Reconstr. 2023 May-Aug;18(2):82-86. doi: 10.5005/jp-journals-10080-1587.
• Background Trimmel H, Egger A, Doppler R, Pimiskern M, Voelckel WG. Usability and effectiveness of inhaled methoxyflurane for prehospital analgesia - a prospective, observational study. BMC Emerg Med. 2022 Jan 15;22(1):8. doi: 10.1186/s12873-021-00565-6.
• Background Mercadante S, Voza A, Serra S, Ruggiano G, Carpinteri G, Gangitano G, Intelligente F, Bonafede E, Sblendido A, Farina A, Soldi A, Fabbri A; MEDITA Study Group. Analgesic Efficacy, Practicality and Safety of Inhaled Methoxyflurane Versus Standard Analgesic Treatment for Acute Trauma Pain in the Emergency Setting: A Randomised, Open-Label, Active-Controlled, Multicentre Trial in Italy (MEDITA). Adv Ther. 2019 Nov;36(11):3030-3046. doi: 10.1007/s12325-019-01055-9. Epub 2019 Oct 12.
• Background Locke JA, Neu S, Lawrence J, Herschorn S. Pilot study to assess the feasibility of self-administered, low-dose methoxyflurane for cystoscopic procedures. Can Urol Assoc J. 2024 Aug;18(8):251-254. doi: 10.5489/cuaj.8676.
• Background Nguyen NQ, Toscano L, Lawrence M, Moore J, Holloway RH, Bartholomeusz D, Lidums I, Tam W, Roberts-Thomson IC, Mahesh VN, Debreceni TL, Schoeman MN. Patient-controlled analgesia with inhaled methoxyflurane versus conventional endoscopist-provided sedation for colonoscopy: a randomized multicenter trial. Gastrointest Endosc. 2013 Dec;78(6):892-901. doi: 10.1016/j.gie.2013.05.023. Epub 2013 Jun 28.
• Background Nguyen NQ, Burgess J, Debreceni TL, Toscano L. Psychomotor and cognitive effects of 15-minute inhalation of methoxyflurane in healthy volunteers: implication for post-colonoscopy care. Endosc Int Open. 2016 Nov;4(11):E1171-E1177. doi: 10.1055/s-0042-115409. Epub 2016 Nov 8.
• Background Sairally BZF, Smith PP, De Silva PM, O'Connor S, Yates C, Clark TJ. Inhaled methoxyflurane (Penthrox(R)) as a novel pain relief for outpatient hysteroscopy and other gynaecological procedures. Eur J Obstet Gynecol Reprod Biol. 2024 Nov;302:206-210. doi: 10.1016/j.ejogrb.2024.09.002. Epub 2024 Sep 6.
• Background Ahmad G, Saluja S, O'Flynn H, Sorrentino A, Leach D, Watson A. Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev. 2017 Oct 5;(10)(10):CD007710. doi: 10.1002/14651858.CD007710.pub3.
• Background De Silva PM, Mahmud A, Smith PP, Clark TJ. Analgesia for Office Hysteroscopy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1034-1047. doi: 10.1016/j.jmig.2020.01.008. Epub 2020 Jan 23.
• Background Dias AV, Zeidan Z, Copp M, Eslabra F, Hassan R, Middleton R. Penthrox Is an Effective Analgesic but Is It Patient Approved? Cureus. 2024 Feb 4;16(2):e53537. doi: 10.7759/cureus.53537. eCollection 2024 Feb.
• Background Smith MD, Rowan E, Spaight R, Siriwardena AN. Evaluation of the effectiveness and costs of inhaled methoxyflurane versus usual analgesia for prehospital injury and trauma: non-randomised clinical study. BMC Emerg Med. 2022 Jul 7;22(1):122. doi: 10.1186/s12873-022-00664-y.
• Background 14. Wong KY, JS Ki Lau, AY Chung Siu, PG Kan. A randomized non-inferiority pilot study on the use of methoxyflurane (Penthrox) for pain control in the emergency department. Hong Kong Journal of Emergency Medicine 29:203-211.
• Background Elterman DS, Zorn KC, Bhojani N, Chughtai B. Efficacy and safety of methoxyflurane (Penthrox) for pain control during water vapor thermal therapy (Rezum) for benign prostatic enlargement. Can J Urol. 2022 Dec;29(6):11355-11360.
• Background Twidale EK, Neutens S, Hynt L, Dudley N, Streeton C. Methoxyflurane analgesia for outpatient hysteroscopy: A double-blind, randomised, controlled trial. Aust N Z J Obstet Gynaecol. 2025 Feb;65(1):69-76. doi: 10.1111/ajo.13861. Epub 2024 Jul 15.
• Background Stewart AJ, Brooker C, Vose G, Redmond K, Williams A, Pankhania N, Dommett H, Kirk-Bayley J, Franklin AP, Morrison B. Pain and symptom relief using inhaled methoxyflurane for gynecologic brachytherapy applicator removal. J Contemp Brachytherapy. 2023 Feb;15(1):37-42. doi: 10.5114/jcb.2023.125581. Epub 2023 Feb 28.
• Background Hayne D, Grummet J, Espinoza D, McCombie SP, Chalasani V, Ford KS, Frydenberg M, Gilling P, Gordon B, Hawks C, Konstantatos A, Martin AJ, Nixon A, O'Brien C, Patel MI, Sengupta S, Shahbaz S, Subramaniam S, Williams S, Woo HH, Stockler MR, Davis ID, Buchan N; Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). 'Pain-free TRUS B': a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501). BJU Int. 2022 May;129(5):591-600. doi: 10.1111/bju.15552. Epub 2021 Jul 30.
• Background Copping R, Balamon P, Lau M, Catt J, Schlaphoff G. MethOxyfluraNe in InTerventiOnal Radiology (MONITOR): A randomised controlled trial. J Med Imaging Radiat Oncol. 2024 Sep;68(6):705-713. doi: 10.1111/1754-9485.13726. Epub 2024 Jun 25.
• Background Spruyt O, Westerman D, Milner A, Bressel M, Wein S. A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy. BMJ Support Palliat Care. 2014 Dec;4(4):342-8. doi: 10.1136/bmjspcare-2013-000447. Epub 2013 Jun 7.
• Background Methoxyflurane Inhalation as an Analgesic for Minor Gynecological, Ambulatory, or Emergency Procedures: Rapid Review [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2024 Sep. Report No.: RC1545. Available from http://www.ncbi.nlm.nih.gov/books/NBK608473/
• Background Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.
• Background 23. Sealed Envelope Ltd. 2012. Power calculator for continuous outcome non-inferiority trial. [Online] Available from: https://www.sealedenvelope.com/power/continuous-noninferior/ [Accessed Wed Feb 05 2025].

Drugs

Indications

No indication recorded.