Article Text

PDF
A randomised, double-blind, placebo-controlled study to assess the safety and efficacy of methoxyflurane for procedural pain of a bone marrow biopsy
  1. Odette Spruyt1,
  2. David Westerman2,
  3. Alvin Milner3,
  4. Mathias Bressel3 and
  5. Simon Wein4
  1. 1Department of Pain and Palliative Care, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  2. 2Department of Haematology, Peter MacCallum Cancer Centre/University of Melbourne, Melbourne, Victoria, Australia
  3. 3Centre for Biostatistics & Clinical Trials, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  4. 4Palliative Medicine, Davidoff Cancer Centre, Rabin Medical Centre, Petah-Tikva, Israel
  1. Correspondence to Dr Odette Spruyt, Department of Pain and Palliative Care, Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne, VIC 3002, Australia; Odette.Spruyt{at}petermac.org

Abstract

Context Pain during bone marrow biopsy (BMB) under local anaesthesia (LA) is reported in 70% of patients, of whom 35% rate the pain as severe. Pain is experienced during both the biopsy and the marrow aspiration. Many medical centres use conscious sedation involving benzodiazepines and/or opioids administered orally or intravenously for BMB analgesia. Methoxyflurane (MEOF) is self-administered by a handheld device (the Penthrox inhaler), which is licensed in Australia for the relief of pain associated with short surgical procedures.

Objectives To evaluate the efficacy and safety of MEOF analgesia in patients with cancer undergoing BMB.

Methods Patients received LA plus either MEOF or placebo. The primary endpoint was worst pain intensity measured with the Numerical Rating Scale. Anxiety was assessed with the State Trait Anxiety Inventory (STAI-Y-1). Patients, operators and the research nurse rated global medication performance using a 5-point Likert scale.

Results Forty-nine of the 50 patients randomised to MEOF and 48 of the 50 patients randomised to placebo effectively received the allocated intervention. Mean±SD worst pain overall was 4.90±2.07 in MEOF group and 6.0±2.24 in placebo group (p=0.011). Worst pain during the aspiration was 3.3±2.0 in MEOF group and 5.0±2.4 in placebo group (p<0.001). 49% of patients treated with MEOF rated the medication as very good or excellent compared with 16.5% of the patients treated with placebo (p=0.005). 20.4% of patients treated with MEOF had an adverse event (AE) compared with 4.2% in the placebo arm (p=0.028). All AEs were grade 1.

Conclusions MEOF was safe and performed better than placebo for analgesia in BMB procedures.

Statistics from Altmetric.com

  • Received 10 January 2013.
  • Revision received 18 April 2013.
  • Accepted 8 May 2013.
View Full Text

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.