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A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department

Primary Purpose

Acute Traumatic Pain

Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Methoxyflurane
Ketorolac
Sponsored by
Hospital Authority, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Traumatic Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

    1. Known personal or family history of hypersensitivity to methoxyflurane or any fluorinated anesthetics
    2. Known pre-existing clinically significant renal or hepatic impairment
    3. Known personal or family history of malignant hyperthermia
    4. Concomitant use of nephrotoxic agents such as gentamicin, tetracycline, colistin, polymyxin B and amphotericin B
    5. Concomitant use of cytochrome P450 inducers such as alcohol, isoniazid, phenobarbital and rifampicin

  • Contraindication to intramuscular ketorolac

    1. Known allergy to NSAIDS
    2. Known pre-existing clinically significant renal impairment or at risk for renal failure due to volume depletion
    3. Active major bleeding
    4. Suspected or confirmed cerebrovascular bleeding
    5. History of peptic ulcer disease, gastrointestinal bleeding or perforation
    6. Concomitant use of aspirin, other NSAIDS, anticoagulant or novel anticoagulant agent, pentoxifylline and probenecid
    7. Known bleeding disorders such as haemophilia, thrombocytopenia
    8. Heart failure
    9. Per-operative period of coronary artery bypass graft (CABG) surgery
    10. Concurrent asthmatic attack

Sites / Locations

  • Hospital Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Inhalational methoxyflurane (Penthrox)

Intramuscular ketorolac

Arm Description

Outcomes

Primary Outcome Measures

The change in pain intensity over 60 mins in terms of 100-mm VAS
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".

Secondary Outcome Measures

Blood pressure
Blood pressure in mmHg
Pulse Rate
Pulse Rate in beat per minute
Oxygen saturation
Oxygen saturation in %
Level of sedation
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.
Drug-related adverse events
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.
Use of rescue medication
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.
Level of patient's satisfaction
Patients are instructed to rate the overall efficacy and acceptance of the drug by five-point Likert scale on a questionnaire.

Full Information

First Posted
October 23, 2020
Last Updated
December 6, 2020
Sponsor
Hospital Authority, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04618497
Brief Title
A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department
Official Title
A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
November 21, 2020 (Actual)
Study Completion Date
November 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Authority, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Traumatic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be enrolled on a convenience basis. After being seen and screened by investigators, patients who meet all inclusion and non-exclusion criteria will be enrolled and randomized 1:1 by drawing from equal preset numbers of envelopes. Patients will receive either inhalational methoxyflurane or intramuscular ketorolac. Patients and investigators are not blinded to the treatment due to the nature of drug administration.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhalational methoxyflurane (Penthrox)
Arm Type
Experimental
Arm Title
Intramuscular ketorolac
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Methoxyflurane
Other Intervention Name(s)
Penthrox
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in pain intensity over 60 mins in terms of 100-mm VAS
Description
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".
Time Frame
Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure in mmHg
Time Frame
Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Title
Pulse Rate
Description
Pulse Rate in beat per minute
Time Frame
Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Title
Oxygen saturation
Description
Oxygen saturation in %
Time Frame
Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Title
Level of sedation
Description
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.
Time Frame
Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Title
Drug-related adverse events
Description
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.
Time Frame
After drug administration until the end of the observation period (1 hour)
Title
Use of rescue medication
Description
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.
Time Frame
After drug administration until the end of the observation period (1 hour)
Title
Level of patient's satisfaction
Description
Patients are instructed to rate the overall efficacy and acceptance of the drug by five-point Likert scale on a questionnaire.
Time Frame
After drug administration until the end of the observation period (1 hour)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Ying Wong, MB ChB
Organizational Affiliation
Hospital Authority, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Authority
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department

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