- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618497
A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department
December 6, 2020 updated by: Wong Ka Ying, Hospital Authority, Hong Kong
Patients commonly visit the emergency department (ED) for pain after musculoskeletal injury and need early treatment with analgesic.
Prompt and adequate pain relief can reduce suffering and promote early discharge and return to work.
Nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are the major injectable analgesic used for moderate to severe pain in EDs in Hong Kong.
They are given via intravenous or intramuscular route for faster onset of action to achieve rapid pain relief in the emergency setting.
However, injections are invasive and can be distressing for patients.
Methoxyflurane (Penthrox®) is recently introduced to our emergency department as an inhalational analgesic.
It has been granted registration approval in Hong Kong since 2018, but it is not widely used in the locality.
Methoxyflurane is a volatile fluorinated hydrocarbon self-administrated by inhalation through a portable hand-held whistle-shaped inhaler device (Penthrox®) to relieve pain associated with trauma or minor surgical procedures in stable and conscious patients.
In this study, the investigators will evaluate the efficacy and safety Penthrox® in the treatment of acute traumatic pain in hospital emergency department setting by comparing it to another conventional analgesic commonly used.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- Hospital Authority
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of both sexes from 18 to 64 years of age
- Presented to the ED in Ruttonjee Hospital for musculoskeletal injury within 72 hours of onset (Types of injury include contusion, sprain, crushing, burn, laceration, fracture and dislocation)
- Moderate pain at screening (10-point Numeric Rating Scale ≥4 to ≤7)
Exclusion Criteria:
- Critical or life-threatening condition requiring resuscitation
- Limb-threatening condition or any injuries requiring immediate management
- Hemodynamically unstable (systolic blood pressure <90 mmHg, diastolic blood pressure <60mmHg)
- Respiratory distress with respiratory rate >20 breath per minute or oxygen saturation <95% on room air
- Pregnant or breastfeeding women
- Impaired consciousness from any cause such as head injury and acute intoxication, based on the judgement of investigator
- Any physical, visual or cognitive conditions that may affect patient's ability to use visual analog scale for self-assessments of pain intensity
- Concomitant use of other analgesic within 5 hours (8 hours for diclofenac sodium) prior to presentation to ED
- Other pre-existing chronic pain condition
- Unable or refuse to provide written informed consent
- Unable to understand and converse in the language spoken
Contraindication to inhalational methoxyflurane
- Known personal or family history of hypersensitivity to methoxyflurane or any fluorinated anesthetics
- Known pre-existing clinically significant renal or hepatic impairment
- Known personal or family history of malignant hyperthermia
- Concomitant use of nephrotoxic agents such as gentamicin, tetracycline, colistin, polymyxin B and amphotericin B
- Concomitant use of cytochrome P450 inducers such as alcohol, isoniazid, phenobarbital and rifampicin
Contraindication to intramuscular ketorolac
- Known allergy to NSAIDS
- Known pre-existing clinically significant renal impairment or at risk for renal failure due to volume depletion
- Active major bleeding
- Suspected or confirmed cerebrovascular bleeding
- History of peptic ulcer disease, gastrointestinal bleeding or perforation
- Concomitant use of aspirin, other NSAIDS, anticoagulant or novel anticoagulant agent, pentoxifylline and probenecid
- Known bleeding disorders such as haemophilia, thrombocytopenia
- Heart failure
- Per-operative period of coronary artery bypass graft (CABG) surgery
- Concurrent asthmatic attack
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inhalational methoxyflurane (Penthrox)
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Each patient in the methoxyflurane group will use one Penthrox inhaler under supervision of trained personnel.
After priming the inhaler with 3 mL of methoxyflurane, patient is instructed to inhale through the mouthpiece to obtain analgesia, and then exhale back into the mouthpiece so that any unmetabolized methoxyflurane can be adsorbed by activated charcoal chamber.
First few breaths should be gentle and then breathe normally through Inhaler.
Onset of pain relief is rapid and occurs after 6-10 inhalations.
If stronger analgesia is required, patient can cover the diluter hole with a finger during inhalation.
Patients are able to titrate the amount of methoxyflurane inhaled and should be instructed to inhale intermittently to achieve adequate pain control.
Other Names:
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Active Comparator: Intramuscular ketorolac
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Each patient in the ketorolac group will receive one dose of 30mg intramuscular ketorolac injected at gluteal muscle by nursing staff as usual daily practice.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in pain intensity over 60 mins in terms of 100-mm VAS
Time Frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Patients are instructed to complete a questionnaire with visual analogue scale (VAS), a 100-mm horizontal straight line whereas"0" at the left end indicates "no pain at all" and "10" at the right end indicates "the worst possible pain I can imagine".
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Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Blood pressure in mmHg
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Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Pulse Rate
Time Frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Pulse Rate in beat per minute
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Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Oxygen saturation
Time Frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Oxygen saturation in %
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Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Level of sedation
Time Frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Ramsay Sedation Scale 1-6. 1 indicates patient is anxious and agitated or restless, or both; 2 indicates patient is co-operative, oriented, and tranquil; 3 indicates patient responds to commands only; 4 indicates patient exhibits brisk response to light glabellar tap or loud auditory stimulus; 5 indicates patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; 6 indicates patient exhibits no response.
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Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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Drug-related adverse events
Time Frame: After drug administration until the end of the observation period (1 hour)
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Patients are advised to report any discomfort any time during the study period.
The investigator would judge whether the complaint is drug-related and give corresponding treatment.
If the patients have no active complaint, they would be asked on a checklist for possible related adverse events before discharge.
The nature and severity of adverse events would be documented.
To exclude any late effects, discharged patients are encouraged to return to the department if they experience any adverse events.
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After drug administration until the end of the observation period (1 hour)
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Use of rescue medication
Time Frame: After drug administration until the end of the observation period (1 hour)
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Analgesics given after study drug administration in either group are considered as rescue medication.
It will be given any if the patient requests or pain improvement is insufficient based on judgement of the attending physician.
The name of rescue medication, dosage, time and route of administration will be documented.
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After drug administration until the end of the observation period (1 hour)
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Level of patient's satisfaction
Time Frame: After drug administration until the end of the observation period (1 hour)
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Patients are instructed to rate the overall efficacy and acceptance of the drug by five-point Likert scale on a questionnaire.
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After drug administration until the end of the observation period (1 hour)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ka Ying Wong, MB ChB, Hospital Authority, Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 28, 2020
Primary Completion (Actual)
November 21, 2020
Study Completion (Actual)
November 21, 2020
Study Registration Dates
First Submitted
October 23, 2020
First Submitted That Met QC Criteria
October 31, 2020
First Posted (Actual)
November 6, 2020
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 6, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Emergencies
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anesthetics, General
- Anesthetics
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Anesthetics, Inhalation
- Ketorolac
- Methoxyflurane
Other Study ID Numbers
- HKECREC-2020-064
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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