Acute Traumatic PainPhase 3NCT04618497
A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department
A Phase 3 study testing Methoxyflurane and Ketorolac in people with Acute Traumatic Pain, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Traumatic Pain
- What is being tested?
- Methoxyflurane and Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Oct 2020to 21 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Acute Traumatic Pain
- Being tested
- Methoxyflurane, Ketorolac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox
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.
KetorolacDrug
Also called Toradol
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhalational methoxyflurane (Penthrox) | Experimental | Not described Receives: Drug: Methoxyflurane |
| Intramuscular ketorolac | Active comparator | Not described Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Secondary outcomes (7)
Blood pressure
Blood pressure in mmHg
Measured: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Pulse Rate
Pulse Rate in beat per minute
Measured: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Oxygen saturation
Oxygen saturation in %
Measured: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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.
Measured: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
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.
Measured: After drug administration until the end of the observation period (1 hour)
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.
Measured: After drug administration until the end of the observation period (1 hour)
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.
Measured: After drug administration until the end of the observation period (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start28 Oct 2020
- Primary completion21 Nov 2020
- Study completion21 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Traumatic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wong Ka Ying, Hospital Authority, Hong Kong
- Investigators
- Ka Ying Wong, MB ChB, Principal investigator, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618497
- Sponsor's protocol ID
- HKECREC-2020-064
- Status last verified
- Dec 2020
- First submitted
- 23 Oct 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Use of Methoxyflurane (Penthrox®) for Pain Control in the Emergency Department
- ClinicalTrials.gov ID
- NCT04618497
- Acronym / sponsor ID
- HKECREC-2020-064
- Conditions
- Acute Traumatic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 21 Nov 2020 (actual)
- Study completion
- 21 Nov 2020 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Inhalational methoxyflurane (Penthrox) | Experimental | Drug: Methoxyflurane |
| Intramuscular ketorolac | Active comparator | Drug: Ketorolac |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethoxyfluraneAlso: PenthroxEach 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. | Drug | Inhalational methoxyflurane (Penthrox) |
| KetorolacAlso: ToradolEach patient in the ketorolac group will receive one dose of 30mg intramuscular ketorolac injected at gluteal muscle by nursing staff as usual daily practice. | Drug | Intramuscular ketorolac |
Primary outcome
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
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".
7 secondary outcomes
Blood pressure
Time frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Pulse Rate
Time frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Oxygen saturation
Time frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Level of sedation
Time frame: Measure at baseline and at 5, 15, 30 and 60 minutes after drug administration
Drug-related adverse events
Time frame: After drug administration until the end of the observation period (1 hour)
Use of rescue medication
Time frame: After drug administration until the end of the observation period (1 hour)
Level of patient's satisfaction
Time frame: After drug administration until the end of the observation period (1 hour)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Ying Wong, MB ChB principal investigator
Hospital Authority, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxyflurane and Ketorolac in people with Acute Traumatic Pain, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.