PENTHROX™ - Methoxyflurane History and Experience in the Management of Pain

Clinical Need Inherent need to offer patients analgesia for existing or potential pain Current options: Local anaesthetics, oral analgesics, narcotics and … Delete ‘with’

Clinical Need Current analgesic options may be less than ideal due to: Limited efficacy Inconvenient administration Length of onset or duration of action Adverse reactions (e.g., respiratory depression)

Methoxyflurane Originally a general anaesthetic agent Now Contraindicated due to safety concerns with dose Unique in producing powerful analgesic properties at very low sub-anaesthetic concentrations Currently indicated for trauma and minor surgical procedures Needs NO pre-medication or fasting Bold ‘very low’ Add last line 4

Features of Methoxyflurane Potent analgesic with rapid onset (6 – 10 breaths) Demonstrated cardiovascular and respiratory stability No significant adverse effects Can be administered easily to patients of virtually all ages

Penthrox™ Inhaler The Penthrox™ Inhaler is a tubular light-weight disposable inhaler device that features: Internal wick (absorption matrix) Dilutor hole enables two concentrations One-way valve to prevent blow-back 22mm mouthpiece – connects to face mask

Intermittent Usage of Methoxyflurane Use intermittently as needed, or just before planned possible painful stage during intervention

Assisting the Patient to Manage Pain Best to empower the patient to self-administer intermittently Gentle assistance/direction as needed Patient may close eyes as they relax, rarely drowsy – easily roused Recovery is quick

Clinical Studies The analgesic safety and efficacy of methoxyflurane has been evaluated in a variety of areas: Pre-hospital Emergency Burns Dental Obstetrics Aesthetic surgery Delete ‘active ingredient’ 9

Case Series (Buntine, 2007) 83 adult patients receiving paramedical assistance and transport to urban teaching hospital Age range = 17 to 95 years Methoxyflurane administered via Penthrox™ Inhaler Administration duration = median of 29 minutes Indication included musculoskeletal injury, visceral pain and back pain

Case Series (Buntine): Results Statistically significant reduction in pain scores compared with baseline (p < 0.0001)

Case Series (Babl, 2006): 105 paediatric patients receiving paramedical assistance and transport to tertiary children’s hospital Age range = 15 months to 17 years Methoxyflurane administered via Penthrox Inhaler Administration duration = median of 20 minutes No pre-medications, no food or fluid restrictions

Case Series (Babl): Results Methoxyflurane administration resulted in a 43.0% reduction in pain scores within 10 minutes 88.5% of paramedics were satisfied to very satisfied with the level of patient analgesia 87.0% of patients were satisfied to very satisfied with the level of analgesia 96.9% of primary care providers and older patients would want to use Methoxyflurane again for pain control

Clinical Poster (Wilkes and Oxer, 2007): 17,344 patients receiving paramedical assistance and transport to hospital Age range = 2 years to 95+ years Methoxyflurane administered via Penthrox Inhaler = 13,313 patients Fentanyl administered intra-nasally = 4,021 patients No pre-medications, no food or fluid restrictions

Clinical Poster (Wilkes and Oxer): Results Good / excellent relief Partial relief No relief Methoxyflurane 54.3% 38.4% 7.3% Intra-nasal fentanyl 52.9% 39.8% 7.4% No significant side effects reported Methoxyflurane particularly useful in children Analgesia from methoxyflurane found to be equivalent to intra-nasal fentanyl

Examples of Use – Ambulance and Rescue Physical trauma Domestic trauma Motor vehicle accidents Pain / injury Mass casualty Emergency rescue

Hospital Accident and emergency Minor surgical procedures Burns / wound management Radiology Oncology Acute pain services Add ‘with’ 17

First Response Worksite injuries Sporting injuries Injuries at mass public gatherings Physical trauma Mass Trauma Remote Areas

Methoxyflurane Use – Severe Burns Patient with severe burns and excruciating pain – immersed in water to cool Immediate relief from suffering watch patient’s face Clinical team can immediately treat patient

Potential Population Patients who may benefit include those: In pain Anxious Pain intolerant Dislike of needles or injections Uncooperative Preparing for a painful procedure

Summary Methoxyflurane has been clinically demonstrated over many years to be a safe and effective agent offering patients comfort and relief from pain ‘Over many years’ 22