Pain AcutePhase 2/3MEOPA-PANCT01990404
Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain
A Phase 2/3 study testing Premixed 50% nitrous oxide and oxygen and Medical Air in people with Pain Acute, run by University Hospital, Toulouse at 3 sites in 2 countries.
Trial summary
Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Pain Acute
- What is being tested?
- Premixed 50% nitrous oxide and oxygen and Medical Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2013to Jun 2016
- Phase
- Phase 2/3
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients aged 65 years old and over
- Severe acute pain (NRS score greater than 6)
Who cannot join
- Contraindication of premixed 50% nitrous oxide and oxygen
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study
Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain
Read the detailed description
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 108 patients assigned in two parallel groups, defined by a randomization scheme. Four sites will participate to the research. Eligible patients with a numeric rating scale (NRS) score higher than 6/10 are randomly allocated to receive either MEOPA, or medical air. Neither the investigator nor the nurse knows the treatment. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, and oxygen saturation by pulse oximetry (SpO2) and adverse events collection.
- Conditions
- Pain Acute
- Being tested
- Premixed 50% nitrous oxide and oxygen, Medical Air
- Keywords
- Premixed nitrous oxide and oxygen, Severe acute pain, Prehospital setting
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premixed 50% nitrous oxide and oxygenDrug
Also called MEOPA
Premixed 50% nitrous oxide and oxygen is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B.
Medical AirDrug
Medical air is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B
| Study group | Role | What they receive |
|---|---|---|
| Premixed 50% nitrous oxide and oxygen | Active comparator | The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. Premixed 50% nitrous oxide and oxygen is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10. Receives: Drug: Premixed 50% nitrous oxide and oxygen |
| Medical air | Placebo comparator | The patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. The medical air is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10. Receives: Drug: Medical Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
Measured: 15 minutes after randomisation
Secondary outcomes (3)
adverse events
Measured: From the randomization until 48 hours after randomization
time to analgesia
Measured: From randomization until 48 hours
Duration of analgesia.
Measured: From randomization until 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015
- Study completionJun 2016
Why it stopped: inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Bounes, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990404
- Sponsor's protocol ID
- RC31/12/066
- Other IDs
- 2012-004129-25
- Acronym
- MEOPA-PA
- Status last verified
- Feb 2018
- First submitted
- 27 Sep 2013
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones JS, Johnson K, McNinch M. Age as a risk factor for inadequate emergency department analgesia. Am J Emerg Med. 1996 Mar;14(2):157-60. doi: 10.1016/S0735-6757(96)90123-0.
PubMed 8924137Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
PubMed 15039693Doan BD. [Aging of population and medical workforce: a prospective view of health care provision in France in the year 2025]. Cah Sociol Demogr Med. 2004 Apr-Jun;44(2):243-66. French.
PubMed 15241964Strange GR, Chen EH. Use of emergency departments by elder patients: a five-year follow-up study. Acad Emerg Med. 1998 Dec;5(12):1157-62. doi: 10.1111/j.1553-2712.1998.tb02688.x.
PubMed 9864128
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Premixed Nitrous Oxide and Oxygen in Elderly Patient With Out-of-hospital Severe Acute Pain: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT01990404
- Acronym / sponsor ID
- MEOPA-PA / RC31/12/066
- Conditions
- Pain Acute
- Keywords
- Premixed nitrous oxide and oxygen, Severe acute pain, Prehospital setting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate recruitment
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Nov 2013 (estimated)
- 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.
Pain in the elderly is poorly evaluated and clearly under treated. Premixed nitrous oxide and oxygen is used in the emergency medical care of the trauma, burns, during transport of patient with pain. None randomized study has validated the use of premixed nitrous oxide and oxygen in the emergency department in the elderly. The aim of the study is to demonstrate the efficacy of premixed nitrous oxide and oxygen compared to medical air in elderly patient with out-of-hospital severe acute pain
Detailed description
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) 15 minutes after randomisation. Secondary endpoints are treatment safety and adverse events, time to analgesia and duration of analgesia. This study will expect 108 patients assigned in two parallel groups, defined by a randomization scheme. Four sites will participate to the research. Eligible patients with a numeric rating scale (NRS) score higher than 6/10 are randomly allocated to receive either MEOPA, or medical air. Neither the investigator nor the nurse knows the treatment. Pain score will be measured at baseline and every 5 minutes until pain relief will be obtained. The safety evaluation will include non invasive monitoring of blood pressure, heart rate, and oxygen saturation by pulse oximetry (SpO2) and adverse events collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premixed 50% nitrous oxide and oxygen | Active comparator | Drug: Premixed 50% nitrous oxide and oxygenThe patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. Premixed 50% nitrous oxide and oxygen is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10. |
| Medical air | Placebo comparator | Drug: Medical AirThe patient will be taken care by the physician SMUR or home emergency. Upon acceptance of participation in the study, the clock will be started at the time of the establishment of the face mask. The medical air is administered for 30 minutes and an opioid titration is started 10 minutes after the introduction of gas, unless the patient expresses pain score EN <3/10. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients aged 65 years old and over
- Severe acute pain (NRS score greater than 6)
Key exclusion criteria (1 listed)
- Contraindication of premixed 50% nitrous oxide and oxygen
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 |
|---|---|---|
| Premixed 50% nitrous oxide and oxygenAlso: MEOPAPremixed 50% nitrous oxide and oxygen is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B. | Drug | Premixed 50% nitrous oxide and oxygen |
| Medical AirMedical air is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B | Drug | Medical air |
Primary outcome
The primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower)
Time frame: 15 minutes after randomisation
3 secondary outcomes
adverse events
Time frame: From the randomization until 48 hours after randomization
time to analgesia
Time frame: From randomization until 48 hours
Duration of analgesia.
Time frame: From randomization until 48 hours
Results and safety
The study was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 8924137Jones JS, Johnson K, McNinch M. Age as a risk factor for inadequate emergency department analgesia. Am J Emerg Med. 1996 Mar;14(2):157-60. doi: 10.1016/S0735-6757(96)90123-0.
- Background: PubMed 15039693Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
- Background: PubMed 15241964Doan BD. [Aging of population and medical workforce: a prospective view of health care provision in France in the year 2025]. Cah Sociol Demogr Med. 2004 Apr-Jun;44(2):243-66. French.
- Background: PubMed 9864128Strange GR, Chen EH. Use of emergency departments by elder patients: a five-year follow-up study. Acad Emerg Med. 1998 Dec;5(12):1157-62. doi: 10.1111/j.1553-2712.1998.tb02688.x.
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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.
Vincent Bounes, MD principal investigator
University Hospital of Toulouse
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Premixed 50% nitrous oxide and oxygen and Medical Air in people with Pain Acute, run by University Hospital, Toulouse at 3 sites in 2 countries.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Reunion. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: inadequate recruitment). Results are not available in the source record.
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 primary endpoint is the percentage of patients with pain relief (with a numerical rating scale of 3/10 or lower) (time frame: 15 minutes after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990404, which also lists 4 linked publications.
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 5 Feb 2018.