Pain, AcutePhase 4Pen ASAPNCT03798899
Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma
A Phase 4 study testing Methoxyflurane and Normal Saline in people with Pain, Acute, run by Mundipharma SAS at 8 sites in France.
Trial summary
A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Methoxyflurane and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 8 sitesFrance
- Study dates
- 14 May 2018to 20 Dec 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 or older
- Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
- Patients admitted to the emergency department due to a trauma
- Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of admission to emergency departments.
- Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.
Who cannot join
- Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
- Impaired consciousness according to the investigator regardless of the cause, including head trauma or drug or alcohol consumption;
- Acute medicinal or alcohol intoxication, according to the investigator;
- Pregnant woman or woman at risk of pregnancy and not using highly effective contraception methods or known lactation;
- Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
- Treatment with nitrous oxide within 5 hours before presentation at the emergency department;
Show all 17Show fewer
- Use of analgesics for chronic pain;
- Prior use of Penthrox®;
- Use of an investigational product one month before presentation at the emergency department;
- Hypersensitivity to Penthrox® or any other fluoridated anesthetic;
- History of signs of hepatic lesions after use of methoxyflurane or after anaesthesia by a halogenated hydrocarbon;
- Malignant hyperthermia: Known malignant hyperthermia or patient genetic predisposition or patient or family history of serious adverse reactions;
- Clinical evidence of respiratory depression according to the investigator;
- Clinical evidence of cardiovascular instability according to the investigator;
- Clinical renal or hepatic damage, according to the investigator, pre-existing or known;
- Presence of any other clinical condition that can, according to the investigator's opinion, have an impact on the patient's ability to participate in the study or the results of the study.
- Individuals protected by law
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CH Annecy Genevois
Annecy, 74374
GH Carnelle Porte de l'Oise
Beaumont-sur-Oise, 95260
Hôpital Avicenne - APHP
Bobigny, 93000
CHRU Lille
Lille, 59037
Hôpital Edouard Herriot
Lyon, 69437
Hospice civil de Lyon
Pierre-Bénite, 69495
CH René Dubos
Pontoise, 95300
CHU Purpan
Toulouse, 31059
About this study
Official title: Multicentre, Randomised, Double-blind Study Assessing the Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Comparison to a Placebo Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma
A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma
Read the detailed description
On admission, the patient pain score will be measured using a numerical scale (NRS-11) to verify the eligibility of the patient in the study (NRS ≥ 4).
At the time of randomisation, the patient's pain score will be measured using a VAS in order to verify the patient's eligibility for randomisation (VAS ≥ 40).
Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive:
- Either Penthrox® + SoC
- Or placebo + SoC (Figure 1). Randomisation will be stratified by sex, site and according to the baseline pain score (NRS 4-5 for a moderate-intensity pain versus NS 6-10 for a severe-intensity pain).
The IWRS system will be based on the fact of including 50% patients with moderate pain and 50% patients with severe pain.
Close weekly monitoring of this ratio will be set up. The decision to no longer include patients in one of the study subgroups according to pain, if necessary, or to change this ratio, will be made by the Study Sponsor and in agreement with the study investigator-coordinator and the study scientific committee. A minimum of 150 patients will be included in the severe pain subgroup (EN 6-10).
The treatment (preparation of two inhalers, the second only being given to the patient on request) will only be administered once intermittently or continuously to patients on admission to the study (D0, T0).
The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30, 60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed until their discharge from the emergency departments (hospitalization, transfer home, transfer to the operating room) or up to 120 minutes after the initial administration.
A telephone interview will take place 14 (± 2) days after the first treatment administration to assess the medium-term safety of the product.
- Conditions
- Pain, Acute
- Being tested
- Methoxyflurane, Normal Saline
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox®
PENTHROX 3mL inhalation vapour, liquid
Normal SalineDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Penthrox® (Methoxyflurane) | Experimental | Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. Receives: Drug: Methoxyflurane |
| Normal Saline | Placebo comparator | Patients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia.
Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC).
Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief
Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain
Measured: through study completion, maximum of 2 hours
Secondary outcomes (23)
Duration between the start of study treatment (T0) and pain relief reported by the patient
Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: through study completion, maximum of 2 hours
Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
PID for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study. Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: baseline to 5, 10, 15, 20 and 30 minutes
Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Relative pain intensity difference for a given assessment time is equal to the VAS score at T0 minus the VAS score at each assessment time provided in the study divided by the VAS score at T0. Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: baseline to 5, 10, 15, 20 and 30 minutes
Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0
Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: baseline to 5, 10, 15, 20 and 30 minutes
Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: baseline to 5, 10, 15, 20 and 30 minutes
Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Pain measured on PI-VAS, 0-100 where 100 is the highest pain
Measured: baseline to 5, 10, 15, 20 and 30 minutes
Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes
SPID will be calculated by using the pain intensity difference (PID) at each of these assessment times provided in the study. SPID is the sum of the PID at each study assessment time, weighted by using the time elapsed since the previous assessment, and approaches the area under the curve for the PID over time. Relative to the VAS score, the SPID measurement has the advantage of considering individual differences at the level of initial pain intensity (baseline) as well as time.
Measured: baseline to 30 minutes
Proportion of patients attaining an SPID of at least 33%
The proportion of patients attaining an SPID of at least 33% of the maximum possible SPID will be calculated (maximum possible SPID is the the value that would be obtained if the patient was pain free (VAS=0) for the entire study period); this will be considered as corresponding to the responder rate. A % SPID of 33% was previously established as being a clinically significant measurement in pain results.
Measured: through study completion, maximum of 2 hours
Quantity of opioids received (in milligrams of morphine)
Measured: through study completion, maximum of 2 hours
Description of the Standard of Care and concomitant analgesic treatments
Descriptions from the World Health Organization (http://www.who.int/cancer/palliative/painladder/en/): Type of drug, doses, administration periods, and treatment duration
Measured: through study completion, maximum of 2 hours
Sedation score (Ramsay scale)
Measured using the Ramsay sedation scale
Measured: through study completion, maximum of 2 hours
Patient satisfaction score (Likert 0-5 scale)
Satisfaction is rated by patient as Poor, Fair, Good, Very Good or Excellent
Measured: through study completion, maximum of 2 hours
Physician satisfaction scale (Likert 0-5 scale)
Satisfaction is rated by Physician as Poor, Fair, Good, Very Good or Excellent
Measured: through study completion, maximum of 2 hours
Nurse satisfaction scale (Likert 0-5 scale)
Satisfaction is rated by Nurse as Poor, Fair, Good, Very Good or Excellent
Measured: through study completion, maximum of 2 hours
Length of stay (LOS) in emergency
Measured: through study completion, maximum of 2 hours
Assess the time until medical decision to discharge
Measured: through study completion, maximum of 2 hours
Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment
Measured: through study completion, maximum of 2 hours
Change in blood pressure
The Blood Systolic and Diastolic pressure (mmHg) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
Measured: baseline to 30 minutes
Change in oxygen saturation
Oxygen saturation (%) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
Measured: baseline to 30 minutes
Change in respiration rate
Respiration rate (breaths/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
Measured: baseline to 30 minutes
Change in heart rate
Heart rate (beats/min) will be measured at baseline and 30 minutes. The difference between the values will be calculated.
Measured: baseline to 30 minutes
Incidence of tachycardia, hypotension, hypertension and respiratory depression
Measured: through study completion, maximum of 2 hours
Incidence of premature withdrawal of patients for safety or tolerability reasons
Measured: through study completion, maximum of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start14 May 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AXONAL, Exystat
- Responsible party
- Sponsor
- Investigators
- A Ricard-Hibon, Dr, Principal investigator, CHG Pontoise / SAMU 95
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798899
- Sponsor's protocol ID
- MR311-4501
- Other IDs
- 2017-004469-28, 2017
- Acronym
- Pen ASAP
- Status last verified
- Jan 2019
- First submitted
- 9 Nov 2018
- Last updated
- 10 Jan 2019
- 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised, Double-blind Study Assessing the Efficacy and Safety of Penthrox® Combined With a Standard Analgesia (SoC) in Comparison to a Placebo Combined With a Standard Analgesia (SoC) in Adult Patients Admitted to the Emergency Department With Moderate to Severe Pain Associated With Trauma
- ClinicalTrials.gov ID
- NCT03798899
- Acronym / sponsor ID
- Pen ASAP / MR311-4501
- Conditions
- Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Mundipharma SASIndustry (pharma, biotech, devices)
- Collaborators
- AXONAL, Exystat
- Study start
- 14 May 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 10 Jan 2019 (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.
A phase 4 randomised, double-blind study to assess the efficacy and safety of Penthrox® used from the outset in multimodal analgesia, in combination with the standard analgesic protocol used in the department, for conscious adult patients presenting in an emergency department with moderate to severe pain associated with a trauma
Detailed description
On admission, the patient pain score will be measured using a numerical scale (NRS-11) to verify the eligibility of the patient in the study (NRS ≥ 4).
At the time of randomisation, the patient's pain score will be measured using a VAS in order to verify the patient's eligibility for randomisation (VAS ≥ 40).
Admissible patients will be randomised by IWRS (Interactive Web Response System) to receive:
- Either Penthrox® + SoC
- Or placebo + SoC (Figure 1). Randomisation will be stratified by sex, site and according to the baseline pain score (NRS 4-5 for a moderate-intensity pain versus NS 6-10 for a severe-intensity pain).
The IWRS system will be based on the fact of including 50% patients with moderate pain and 50% patients with severe pain.
Close weekly monitoring of this ratio will be set up. The decision to no longer include patients in one of the study subgroups according to pain, if necessary, or to change this ratio, will be made by the Study Sponsor and in agreement with the study investigator-coordinator and the study scientific committee. A minimum of 150 patients will be included in the severe pain subgroup (EN 6-10).
The treatment (preparation of two inhalers, the second only being given to the patient on request) will only be administered once intermittently or continuously to patients on admission to the study (D0, T0).
The pain score will be assessed using the VAS every 5 minutes up to 20 minutes, then at 30, 60, 90, and 120 minutes after the start of study treatment (T0). Patients will be assessed until their discharge from the emergency departments (hospitalization, transfer home, transfer to the operating room) or up to 120 minutes after the initial administration.
A telephone interview will take place 14 (± 2) days after the first treatment administration to assess the medium-term safety of the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Penthrox® (Methoxyflurane) | Experimental | Drug: MethoxyfluranePatients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia. Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. |
| Normal Saline | Placebo comparator | Drug: Normal SalinePatients will be asked to inhale Penthrox® intermittently or continuously to obtain adequate analgesia. Penthrox® or placebo will be administered in combination with standard analgesic treatments usually used according to the emergency department protocol (SoC). Duration of treatment: 1 administration (with a maximum of 2 inhalers) during passage to emergency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 or older
- Patients (in an emergency, parent or relative) who dated and signed their informed consent to participate in the study
- Patients admitted to the emergency department due to a trauma
- Patients having a pain score ≥ 4 measured using a numerical scale (NRS) at the time of admission to emergency departments.
- Patients having a pain score ≥ 40 measured using the VAS at the time of randomisation.
Key exclusion criteria (17 listed)
- Life-threatening conditions requiring immediate admission to the operating theatre or the intensive care unit;
- Impaired consciousness according to the investigator regardless of the cause, including head trauma or drug or alcohol consumption;
- Acute medicinal or alcohol intoxication, according to the investigator;
- Pregnant woman or woman at risk of pregnancy and not using highly effective contraception methods or known lactation;
- Analgesic treatment within 5 hours (8 h for sodium diclofenac) prior to admission, except for paracetamol, which is allowed;
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: Penthrox®PENTHROX 3mL inhalation vapour, liquid | Drug | Penthrox® (Methoxyflurane) |
| Normal SalinePlacebo | Drug | Normal Saline |
Primary outcome
time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief
Time frame: through study completion, maximum of 2 hours
Measured on Pain intensity visual analogue scale (PI-VAS) 0-100 where 100 is the highest pain
23 secondary outcomes
Duration between the start of study treatment (T0) and pain relief reported by the patient
Time frame: through study completion, maximum of 2 hours
Absolute Pain Intensity Difference (PID) measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Time frame: baseline to 5, 10, 15, 20 and 30 minutes
Relative Pain Intensity Difference measured using the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Time frame: baseline to 5, 10, 15, 20 and 30 minutes
Pain relief defined by pain intensity < 40 mm on the PI-VAS scale at 5, 10, 15, 20 and 30 minutes after T0
Time frame: baseline to 5, 10, 15, 20 and 30 minutes
Response defined by pain reduction of 20 mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Time frame: baseline to 5, 10, 15, 20 and 30 minutes
Response defined by pain reduction of 30% mm on the PI-VAS at 5, 10, 15, 20 and 30 minutes after T0
Time frame: baseline to 5, 10, 15, 20 and 30 minutes
Summed Pain Intensity Difference (SPID) measured on the PI-VAS at 5, 10, 15, 20 and 30 minutes
Time frame: baseline to 30 minutes
Proportion of patients attaining an SPID of at least 33%
Time frame: through study completion, maximum of 2 hours
Quantity of opioids received (in milligrams of morphine)
Time frame: through study completion, maximum of 2 hours
Description of the Standard of Care and concomitant analgesic treatments
Time frame: through study completion, maximum of 2 hours
Sedation score (Ramsay scale)
Time frame: through study completion, maximum of 2 hours
Patient satisfaction score (Likert 0-5 scale)
Time frame: through study completion, maximum of 2 hours
Physician satisfaction scale (Likert 0-5 scale)
Time frame: through study completion, maximum of 2 hours
Nurse satisfaction scale (Likert 0-5 scale)
Time frame: through study completion, maximum of 2 hours
Length of stay (LOS) in emergency
Time frame: through study completion, maximum of 2 hours
Assess the time until medical decision to discharge
Time frame: through study completion, maximum of 2 hours
Incidence of adverse events (AE) not associated with the underlying trauma and occurring during treatment
Time frame: through study completion, maximum of 2 hours
Change in blood pressure
Time frame: baseline to 30 minutes
Change in oxygen saturation
Time frame: baseline to 30 minutes
Change in respiration rate
Time frame: baseline to 30 minutes
Change in heart rate
Time frame: baseline to 30 minutes
Incidence of tachycardia, hypotension, hypertension and respiratory depression
Time frame: through study completion, maximum of 2 hours
Incidence of premature withdrawal of patients for safety or tolerability reasons
Time frame: through study completion, maximum of 2 hours
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 10 Jan 2019.
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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.
A Ricard-Hibon, Dr principal investigator
CHG Pontoise / SAMU 95
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane and Normal Saline in people with Pain, Acute, run by Mundipharma SAS at 8 sites in France.
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 5 inclusion and 17 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 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
time until pain relief defined by the duration between the start of the study treatment (T0) and pain relief (time frame: through study completion, maximum of 2 hours). 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 10 Jan 2019.